# FDA PMA 30-day notice decisions: 2,874 since Nov 2024

Updated October 30, 2026.

FDA made 2,874 device decisions of type PMA 30-day notice from November 13, 2024 to October 30, 2026: 0 510(k) clearances and De Novo grants and 2,874 PMA approvals and supplements, for 259 applicants. The newest, P960009/S548 on October 30, 2026, is Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ from Medtronic, Inc..

## The full list

FDA PMA 30-day notice decisions: 2,874 rows for $108.74, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. Columns: Number, Pathway, Device name, Applicant, Applicant address, Contact, Decision, Decision date, Decision type, Date received, Product code, Device type, Device class, Panel, Applicant state, Applicant country, Supplement reason, Read on, Source. The new rows each week by email, about 111 rows a month: $19 a month. Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (contact, pathway, device name, applicant address, decision type, date received and 6 more), which open on your screen as soon as the payment clears and come by email. The rows on this page are a sample.

Buy: https://specstream.ai/data/fda-clearances/decision/pma-30-day-notice

SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

- Decisions: 2,874
- 510(k) and De Novo: 0
- PMA: 2,874
- Latest decision: October 30, 2026

## Newest decisions

The newest 100 of 2,874, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

| Decision date | Number | Device | Applicant | Location | Decision | Type | Product code | Source |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| October 30, 2026 | P960009/S548 | Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ | Medtronic, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | MHY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960009S548) |
| October 30, 2026 | P860004/S465 | SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters | Medtronic, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | LKK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P860004S465) |
| October 30, 2026 | P840001/S636 | Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces-Quad™... | Medtronic Neuromodulation | Minnesota | 30-day notice accepted | PMA 30-day notice | LGW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P840001S636) |
| October 30, 2026 | P170038/S034 | CentriMag™ Circulatory Support System | Abbott | California | 30-day notice accepted | PMA 30-day notice | DSQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170038S034) |
| October 30, 2026 | P150031/S102 | Vercise Deep Brain Stimulation (DBS) Systems | Boston Scientific Corp | California | 30-day notice accepted | PMA 30-day notice | NHL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150031S102) |
| October 30, 2026 | P140009/S144 | Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) | Abbott Medical | Texas | 30-day notice accepted | PMA 30-day notice | MHY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140009S144) |
| October 30, 2026 | P140009/S142 | Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) Charger | Abbott Medical | Texas | 30-day notice accepted | PMA 30-day notice | MHY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140009S142) |
| October 30, 2026 | P010032/S266 | Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) | Abbott Medical | Texas | 30-day notice accepted | PMA 30-day notice | LGW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010032S266) |
| October 30, 2026 | P010032/S264 | Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) Charger | Abbott Medical | Texas | 30-day notice accepted | PMA 30-day notice | LGW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010032S264) |
| October 29, 2026 | P980035/S849 | Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra XT SR MRI IPG; Azure S DR MRI IPG; Azure S... | Medtronic, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | NVZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980035S849) |
| October 29, 2026 | P980016/S967 | Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD | Medtronic Cardiac Rhythm Disease Management | Minnesota | 30-day notice accepted | PMA 30-day notice | LWS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980016S967) |
| October 29, 2026 | P970004/S460 | InterStim™ Therapy System, Verify™ Evaluation System (SNS Urinary Neurostimulator 97800), (SNS Urinary... | Medtronic Neuromodulation | Minnesota | 30-day notice accepted | PMA 30-day notice | EZW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970004S460) |
| October 29, 2026 | P960009/S547 | Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (DBS Neurostimulator Implantable... | Medtronic, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | MHY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960009S547) |
| October 29, 2026 | P860004/S464 | SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters TDD (Drug Delivery Infusion Pump 8667), TDD (Drug... | Medtronic, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | LKK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P860004S464) |
| October 29, 2026 | P840001/S635 | Master Restore™, Itrel™, Synergy Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™... | Medtronic Neuromodulation | Minnesota | 30-day notice accepted | PMA 30-day notice | LGW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P840001S635) |
| October 29, 2026 | P240039/S004 | SetPoint System | SetPoint Medical | California | 30-day notice accepted | PMA 30-day notice | SFJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240039S004) |
| October 29, 2026 | P160026/S076 | LIFEPAK® 35 monitor/defibrillator | Physio-Control, Inc. | Washington | 30-day notice accepted | PMA 30-day notice | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160026S076) |
| October 29, 2026 | P080025/S354 | InterStim™ Therapy System, Verify™ Evaluation System (SNS Bowel Neurostimulator 97800), (SNS Bowel... | Medtronic Neuromodulation | Minnesota | 30-day notice accepted | PMA 30-day notice | QON | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P080025S354) |
| October 29, 2026 | P010031/S934 | Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D | Medtronic Cardiac Rhythm Disease Management | Minnesota | 30-day notice accepted | PMA 30-day notice | NIK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010031S934) |
| October 29, 2026 | P010015/S592 | Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara... | Medtronic, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | LWP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010015S592) |
| October 28, 2026 | P950037/S300 | Amvia Sky DR-T, Amvia Sky SR-T; Amvia Edge DR-T, Amvia Edge SR-T; Solvia Rise DR-T, Solvia Rise SR-T; Amvia... | Biotronik, Inc. | Oregon | 30-day notice accepted | PMA 30-day notice | DXY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P950037S300) |
| October 28, 2026 | P860057/S228 | Carpentier-Edwards PERIMOUNT Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix® tissue process... | Edwards Lifesciences, LLC | California | 30-day notice accepted | PMA 30-day notice | DYE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P860057S228) |
| October 28, 2026 | P250051/S001 | Juveena Hydrogel System | Rejoni, Inc. | Massachusetts | 30-day notice accepted | PMA 30-day notice | MCN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250051S001) |
| October 28, 2026 | P230013/S034 | Edwards EVOQUE Tricuspid Valve Replacement System (9850EV) | Edwards Lifesciences, LLC | California | 30-day notice accepted | PMA 30-day notice | NPW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230013S034) |
| October 28, 2026 | P200045/S025 | RelayPro Thoracic Stent-Graft Delivery System | Bolton Medical, Inc. | Florida | 30-day notice accepted | PMA 30-day notice | MIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200045S025) |
| October 28, 2026 | P200015/S084 | Edwards SAPIEN 3 Transcatheter Heart Valve (9600TFX) | Edwards Lifesciences, LLC | California | 30-day notice accepted | PMA 30-day notice | NPV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200015S084) |
| October 28, 2026 | P160035/S061 | EXCOR Pediatric VAD | Berlin Heart, Inc. | Texas | 30-day notice accepted | PMA 30-day notice | DSQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160035S061) |
| October 28, 2026 | P160013/S023 | Organ Care System (OCS™) Lung System | TransMedics, Inc. | Massachusetts | 30-day notice accepted | PMA 30-day notice | QBA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160013S023) |
| October 28, 2026 | P150048/S104 | INSPIRIS™ RESILIA™ Aortic Valve (11500A), KONECT RESILIA Aortic Valve Conduit (AVC) (11060A), MITRIS RESILIA... | Edwards Lifesciences, LLC | California | 30-day notice accepted | PMA 30-day notice | LWR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150048S104) |
| October 28, 2026 | P150036/S081 | EDWARDS INTUITY Elite Valve System (8300AB) | Edwards Lifesciences, LLC | California | 30-day notice accepted | PMA 30-day notice | LWR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150036S081) |
| October 28, 2026 | P150004/S101 | Dorsal Root Ganglion Stimulation (DRG) EPG | Abbott Medical | Texas | 30-day notice accepted | PMA 30-day notice | PMP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150004S101) |
| October 28, 2026 | P140031/S210 | Edwards SAPIEN 3 Transcatheter Heart Valve (9600TFX), Edwards SAPIEN 3 Ultra Transcatheter Heart Valve... | Edwards Lifesciences, LLC | California | 30-day notice accepted | PMA 30-day notice | NPT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140031S210) |
| October 28, 2026 | P140009/S141 | Deep Brain Stimulation (DBS) EPG | Abbott Medical | Texas | 30-day notice accepted | PMA 30-day notice | MHY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140009S141) |
| October 28, 2026 | P010032/S262 | Spinal Cord Stimulation (SCS) External Pulse Generator (EPG) | Abbott Medical | Texas | 30-day notice accepted | PMA 30-day notice | LGW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010032S262) |
| October 27, 2026 | P830055/S381 | ATTUNE Rotating Platform (RP) Total Knee System, and ATTUNE Revision Rotating Platform (RP) Knee System | Depuy, Inc. | Indiana | 30-day notice accepted | PMA 30-day notice | NJL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P830055S381) |
| October 27, 2026 | P830055/S378 | LCS® Knee System | Depuy, Inc. | Indiana | 30-day notice accepted | PMA 30-day notice | NJL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P830055S378) |
| October 27, 2026 | P250029/S003 | SimpleScreen™ CRC | Freenome, LLC | California | 30-day notice accepted | PMA 30-day notice | PHP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250029S003) |
| October 27, 2026 | P240038/S004 | FINEVISION HP Trifocal IOLs | Beaver Visitec International, Inc. | Massachusetts | 30-day notice accepted | PMA 30-day notice | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240038S004) |
| October 27, 2026 | P200014/S012 | cobas® EZH2 Mutation Test | Roche Molecular System, Inc. | California | 30-day notice accepted | PMA 30-day notice | OWD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200014S012) |
| October 27, 2026 | P190028/S026 | cobas® HPV | Roche Molecular Systems, Inc. | California | 30-day notice accepted | PMA 30-day notice | MAQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190028S026) |
| October 27, 2026 | P170032/S024 | Woven EndoBridge (WEB) Aneurysm Embolization System | MicroVention, Inc. | California | 30-day notice accepted | PMA 30-day notice | OPR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170032S024) |
| October 27, 2026 | P140023/S033 | cobas® KRAS Mutation Test | Roche Molecular Systems, Inc. | California | 30-day notice accepted | PMA 30-day notice | OWD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140023S033) |
| October 27, 2026 | P140009/S143 | Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generator | Abbott Medical | Texas | 30-day notice accepted | PMA 30-day notice | MHY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140009S143) |
| October 27, 2026 | P120019/S044 | cobas® EGFR Mutation Test, v2.0 | Roche | California | 30-day notice accepted | PMA 30-day notice | OWD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P120019S044) |
| October 27, 2026 | P110020/S045 | cobas® BRAF V600 Mutation Test | Roche Molecular Systems, Inc. | California | 30-day notice accepted | PMA 30-day notice | OWD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110020S045) |
| October 27, 2026 | P100020/S066 | cobas® HPV | Roche Molecular Systems, Inc. | California | 30-day notice accepted | PMA 30-day notice | MAQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100020S066) |
| October 27, 2026 | P010032/S265 | Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generator | Abbott Medical | Texas | 30-day notice accepted | PMA 30-day notice | LGW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010032S265) |
| October 26, 2026 | P960043/S138 | Perclose ProStyle Suture-Mediated Closure and Repair System | Abbott Vascular, Inc. | California | 30-day notice accepted | PMA 30-day notice | MGB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960043S138) |
| October 26, 2026 | P250034/S004 | Optune Pax | Novocure, GmbH |  | 30-day notice accepted | PMA 30-day notice | SHC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250034S004) |
| October 26, 2026 | P230042/S010 | Optune Lua | Novocure, GmbH |  | 30-day notice accepted | PMA 30-day notice | SDA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230042S010) |
| October 26, 2026 | P170011/S064 | Impella RP Flex with SmartAssist | Abiomed, Inc. | Massachusetts | 30-day notice accepted | PMA 30-day notice | PYX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170011S064) |
| October 26, 2026 | P010014/S120 | Oxford Partial Knee System | Biomet Manufacturing Corp | Indiana | 30-day notice accepted | PMA 30-day notice | NRA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010014S120) |
| October 23, 2026 | P990075/S071 | Saline-Filled and Spectrum™ Breast Implants | Mentor Worldwide, LLC | California | 30-day notice accepted | PMA 30-day notice | FWM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990075S071) |
| October 23, 2026 | P980035/S848 | Astra S DR MRI IPG (X3DR01); Astra S SR MRI IPG (X3SR01); Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG... | Medtronic, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | NVZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980035S848) |
| October 23, 2026 | P910056/S067 | enVista® Hydrophobic Acrylic Intraocular Lens | Bausch & Lomb, Inc. | California | 30-day notice accepted | PMA 30-day notice | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P910056S067) |
| October 23, 2026 | P250050/S001 | Liverty™ TIPS Stent Graft | Bard Peripheral Vascular, Inc. | Arizona | 30-day notice accepted | PMA 30-day notice | MIR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250050S001) |
| October 23, 2026 | P240044/S008 | Globe® Pulsed Field System; Globe Catheter | Kardium, Inc. |  | 30-day notice accepted | PMA 30-day notice | QZI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240044S008) |
| October 23, 2026 | P240036/S007 | OmniaSecure™ MRI SureScan™ Lead Model 3930M | Medtronic, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | NVY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240036S007) |
| October 23, 2026 | P240005/S010 | enVista Envy™ Hydrophobic Acrylic Intraocular Lens | Bausch & Lomb, Inc. | New York | 30-day notice accepted | PMA 30-day notice | MFK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240005S010) |
| October 23, 2026 | P220026/S019 | Symplicity G3 Renal Denervation RF Generator | Medtronic, Inc. | California | 30-day notice accepted | PMA 30-day notice | QYI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220026S019) |
| October 23, 2026 | P210011/S006 | xT CDx | Tempus AI, Inc. | Illinois | 30-day notice accepted | PMA 30-day notice | PQP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P210011S006) |
| October 23, 2026 | P160035/S060 | EXCOR Pediatric Ventricular Assist Device | Berlin Heart, Inc. | Texas | 30-day notice accepted | PMA 30-day notice | DSQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160035S060) |
| October 23, 2026 | P100016/S028 | CT LUCIA Intraocular Lenses (IOLs) | Carl Zeiss Meditec Production, LLC | California | 30-day notice accepted | PMA 30-day notice | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100016S028) |
| October 23, 2026 | P060028/S063 | MemoryShape™ Breast Implants | Mentor Worldwide, LLC | California | 30-day notice accepted | PMA 30-day notice | FTR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P060028S063) |
| October 23, 2026 | P030053/S093 | MemoryGel™ Breast Implants | Mentor Corp. | California | 30-day notice accepted | PMA 30-day notice | FTR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030053S093) |
| October 23, 2026 | P010015/S591 | Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02); Serena... | Medtronic, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | LWP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010015S591) |
| October 22, 2026 | P980023/S153 | Ilivia Neo 7 VRT DX, Intica Neo 7 VRT DX, Intica Neo 5 VRT DX, Acticor Sky VR-T, Rivacor Sky VR-T, Rivacor... | Biotronik, Inc. | Oregon | 30-day notice accepted | PMA 30-day notice | LWS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980023S153) |
| October 22, 2026 | P950037/S299 | Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6... | Biotronik, Inc. | Oregon | 30-day notice accepted | PMA 30-day notice | DXY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P950037S299) |
| October 22, 2026 | P160055/S058 | RxSight Light Adjustable Lens and Light Delivery Device | Rxsight, Inc. | California | 30-day notice accepted | PMA 30-day notice | PZK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160055S058) |
| October 22, 2026 | P130008/S147 | Model 3150 IPG | Inspire Medical Systems | Minnesota | 30-day notice accepted | PMA 30-day notice | MNQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130008S147) |
| October 22, 2026 | P070008/S184 | Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75... | Biotronik, Inc. | Oregon | 30-day notice accepted | PMA 30-day notice | NKE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P070008S184) |
| October 22, 2026 | P050023/S216 | Ilivia 7 VRT DX, Intica 7 VRT DX, Intica 5 VRT DX, Ilivia 7 VRT, Intica 7 VRT, Intica 5 VRT, Inlexa 7 VRT... | Biotronik, Inc. | Oregon | 30-day notice accepted | PMA 30-day notice | MRM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P050023S216) |
| October 22, 2026 | P000009/S135 | Ilivia Neo 7 DRT, Intica Neo 7 DRT, Intica Neo 5 DRT, Acticor Sky DR-T, Rivacor Sky DR-T, Rivacor Rise DR-T... | Biotronik, Inc. | Oregon | 30-day notice accepted | PMA 30-day notice | MRM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000009S135) |
| October 21, 2026 | P990075/S070 | MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES | Mentor Worldwide, LLC | California | 30-day notice accepted | PMA 30-day notice | FWM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990075S070) |
| October 21, 2026 | P900056/S229 | ROTAPRO™ Rotational Atherectomy System | Boston Scientific Corp | Minnesota | 30-day notice accepted | PMA 30-day notice | MCX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P900056S229) |
| October 21, 2026 | P250016/S006 | Belotero Intense (+) Lidocaine Dermal Filler | Merz North America, Inc. | North Carolina | 30-day notice accepted | PMA 30-day notice | LMH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250016S006) |
| October 20, 2026 | P900056/S228 | ROTAPRO™ Rotational Atherectomy System | Boston Scientific Corp | Minnesota | 30-day notice accepted | PMA 30-day notice | MCX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P900056S228) |
| October 20, 2026 | P230040/S035 | Cordella Pulmonary Artery Sensor System (CorPASS) | Endotronix, Inc. | Illinois | 30-day notice accepted | PMA 30-day notice | MOM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230040S035) |
| October 19, 2026 | P990080/S067 | TECNIS Foldable Acrylic IOL with OptiEdge, Model ZA9003 | Johnson & Johnson Surgical Vision, Inc. | California | 30-day notice accepted | PMA 30-day notice | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990080S067) |
| October 19, 2026 | P980040/S186 | SENSAR 3-Piece Monofocal IOL, SENSAR 1-piece IOL, TECNIS Multi-focal 1-pc, TECNIS 1-PC OptiBlue IOL, TECNIS... | Johnson & Johnson Surgical Vision, Inc. | California | 30-day notice accepted | PMA 30-day notice | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980040S186) |
| October 19, 2026 | P160054/S136 | HeartMate 3 Left Ventricular Assist System | Abbott Medical | California | 30-day notice accepted | PMA 30-day notice | DSQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160054S136) |
| October 19, 2026 | P080010/S032 | TECNIS Multi-focal 3-pc, Model ZMA00 | Johnson & Johnson Surgical Vision, Inc. | California | 30-day notice accepted | PMA 30-day notice | MFK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P080010S032) |
| October 16, 2026 | P860004/S462 | SynchroMed™ Infusion System, Ascenda ™ Intrathecal Catheters | Medtronic, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | LKK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P860004S462) |
| October 16, 2026 | P240039/S003 | Charger SetPoint System | SetPoint Medical | California | 30-day notice accepted | PMA 30-day notice | SFJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240039S003) |
| October 16, 2026 | P230020/S011 | Altius® Direct Electrical Nerve Stimulation System | Neuros Medical, Inc. | California | 30-day notice accepted | PMA 30-day notice | SAZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230020S011) |
| October 16, 2026 | P220021/S009 | DETOUR System | Endologix, LLC | California | 30-day notice accepted | PMA 30-day notice | QWM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220021S009) |
| October 16, 2026 | P200026/S019 | Abre™ Venous Self-Expanding Stent System | Medtronic Vascular, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | QAN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200026S019) |
| October 16, 2026 | P190002/S052 | Saluda Medical Evoke SCS System | Saluda Medical Pty, Ltd. |  | 30-day notice accepted | PMA 30-day notice | LGW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190002S052) |
| October 16, 2026 | P160043/S096 | Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems | Medtronic Vascular | California | 30-day notice accepted | PMA 30-day notice | NIQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160043S096) |
| October 16, 2026 | P160022/S056 | ZOLL R Series Monitor/Defibrillator | ZOLL Medical Corporation | Massachusetts | 30-day notice accepted | PMA 30-day notice | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160022S056) |
| October 16, 2026 | P110023/S069 | EverFlex™ Self-Expanding Peripheral Stent System; EverFlex™ Self-Expanding Peripheral Stent with Entrust™... | Medtronic Vascular, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | NIP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110023S069) |
| October 16, 2026 | P060037/S100 | NexGen® LPS-Flex/LPS Mobile Bearing Knee System | Zimmer, Inc. | Indiana | 30-day notice accepted | PMA 30-day notice | NJL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P060037S100) |
| October 16, 2026 | P060001/S059 | Protégé™ GPS™ Self-Expanding Peripheral Stent System; Protégé™ RX Self-Expanding Carotid Stent System | Medtronic Vascular, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | NIM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P060001S059) |
| October 16, 2026 | P040045/S147 | VISTAKON® (senofilcon A) Brand Contact Lenses | Vistakon, Division of Johnson & Johnson Vision Car | Florida | 30-day notice accepted | PMA 30-day notice | LPM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040045S147) |
| October 16, 2026 | P030045/S011 | Visi-Pro™ balloon-Expandable peripheral stent system | Medtronic Vascular, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | NIO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030045S011) |
| October 16, 2026 | P030036/S162 | MEDTRONIC SELECTSECURE LEAD MODEL 3830 | Medtronic Cardiac Rhythm Disease Management | Minnesota | 30-day notice accepted | PMA 30-day notice | NVN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030036S162) |
| October 15, 2026 | P190002/S051 | Saluda Medical Evoke SCS System | Saluda Medical Pty, Ltd. |  | 30-day notice accepted | PMA 30-day notice | LGW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190002S051) |
| October 15, 2026 | P140018/S050 | VenaSeal™ Closure System | Medtronic Vascular, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | PJQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140018S050) |
| October 15, 2026 | P120002/S036 | S.M.A.R.T. and S.M.A.R.T. ® CONTROL® Vascular Stent Systems; S.M.A.R.T. RADIANZ™ Vascular Stent System | Cordis US Corporation | Florida | 30-day notice accepted | PMA 30-day notice | NIP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P120002S036) |
| October 15, 2026 | P090018/S044 | Esteem® | Envoy Medical Corporation | Minnesota | 30-day notice accepted | PMA 30-day notice | OAF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P090018S044) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Medtronic, Inc. | 376 | October 30, 2026 |
| Abbott Medical | 256 | October 30, 2026 |
| Medtronic Neuromodulation | 135 | October 30, 2026 |
| Medtronic Cardiac Rhythm Disease Management | 133 | October 29, 2026 |
| Boston Scientific Corp | 98 | October 30, 2026 |
| Edwards Lifesciences, LLC | 93 | October 28, 2026 |
| Boston Scientific Corporation | 80 | October 13, 2026 |
| Biotronik, Inc. | 78 | October 28, 2026 |
| Medtronic Vascular, Inc. | 52 | October 16, 2026 |
| W. L. Gore & Associates, Inc. | 51 | June 23, 2026 |
| Boston Scientific | 49 | October 3, 2026 |
| Merz North America, Inc. | 43 | October 21, 2026 |
| DiaSorin, Inc. | 38 | September 24, 2026 |
| Depuy, Inc. | 36 | October 27, 2026 |
| Biosense Webster, Inc. | 35 | September 15, 2026 |
| CooperVision, Inc. | 34 | September 2, 2026 |
| Johnson & Johnson Surgical Vision, Inc. | 31 | October 19, 2026 |
| Cordis US Corporation | 30 | October 15, 2026 |
| Biotronik AG | 24 | September 24, 2026 |
| Bausch & Lomb, Inc. | 23 | October 23, 2026 |

## By panel

| Panel | Decisions | Latest |
| --- | --- | --- |
| [Cardiovascular](https://specstream.ai/data/fda-clearances/panel/cardiovascular) | 1,570 | October 30, 2026 |
| [Neurology](https://specstream.ai/data/fda-clearances/panel/neurology) | 227 | October 30, 2026 |
| [Ophthalmic](https://specstream.ai/data/fda-clearances/panel/ophthalmic) | 207 | October 27, 2026 |
| [Gastroenterology, Urology](https://specstream.ai/data/fda-clearances/panel/gastroenterology-urology) | 190 | October 29, 2026 |
| [General, Plastic Surgery](https://specstream.ai/data/fda-clearances/panel/general-plastic-surgery) | 161 | October 26, 2026 |
| [Orthopedic](https://specstream.ai/data/fda-clearances/panel/orthopedic) | 126 | October 27, 2026 |
| [Microbiology](https://specstream.ai/data/fda-clearances/panel/microbiology) | 86 | October 27, 2026 |
| [Pathology](https://specstream.ai/data/fda-clearances/panel/pathology) | 76 | October 27, 2026 |
| [Immunology](https://specstream.ai/data/fda-clearances/panel/immunology) | 38 | September 22, 2026 |
| [Anesthesiology](https://specstream.ai/data/fda-clearances/panel/anesthesiology) | 36 | October 26, 2026 |
| [Clinical Chemistry](https://specstream.ai/data/fda-clearances/panel/clinical-chemistry) | 33 | September 1, 2026 |
| [Ear, Nose, Throat](https://specstream.ai/data/fda-clearances/panel/ear-nose-throat) | 31 | October 15, 2026 |
| [General Hospital](https://specstream.ai/data/fda-clearances/panel/general-hospital) | 25 | October 30, 2026 |
| [Medical Genetics](https://specstream.ai/data/fda-clearances/panel/medical-genetics) | 25 | October 27, 2026 |
| [Obstetrics/Gynecology](https://specstream.ai/data/fda-clearances/panel/obstetrics-gynecology) | 14 | October 28, 2026 |
| [Dental](https://specstream.ai/data/fda-clearances/panel/dental) | 11 | September 18, 2026 |
| [Physical Medicine](https://specstream.ai/data/fda-clearances/panel/physical-medicine) | 9 | September 16, 2026 |
| [Radiology](https://specstream.ai/data/fda-clearances/panel/radiology) | 5 | October 13, 2026 |
| [Clinical Toxicology](https://specstream.ai/data/fda-clearances/panel/clinical-toxicology) | 4 | August 26, 2026 |

## By state or country

| State or country | Decisions | Latest |
| --- | --- | --- |
| [Minnesota](https://specstream.ai/data/fda-clearances/state/minnesota) | 973 | October 30, 2026 |
| [California](https://specstream.ai/data/fda-clearances/state/california) | 766 | October 30, 2026 |
| [Massachusetts](https://specstream.ai/data/fda-clearances/state/massachusetts) | 122 | October 28, 2026 |
| [Texas](https://specstream.ai/data/fda-clearances/state/texas) | 116 | October 30, 2026 |
| [Arizona](https://specstream.ai/data/fda-clearances/state/arizona) | 88 | October 23, 2026 |
| [Indiana](https://specstream.ai/data/fda-clearances/state/indiana) | 86 | October 27, 2026 |
| [Oregon](https://specstream.ai/data/fda-clearances/state/oregon) | 82 | October 28, 2026 |
| [Illinois](https://specstream.ai/data/fda-clearances/state/illinois) | 69 | October 23, 2026 |
| [Florida](https://specstream.ai/data/fda-clearances/state/florida) | 65 | October 28, 2026 |
| [Wisconsin](https://specstream.ai/data/fda-clearances/state/wisconsin) | 51 | August 3, 2026 |
| [New Jersey](https://specstream.ai/data/fda-clearances/state/new-jersey) | 49 | October 14, 2026 |
| [Washington](https://specstream.ai/data/fda-clearances/state/washington) | 33 | October 29, 2026 |
| [Colorado](https://specstream.ai/data/fda-clearances/state/colorado) | 28 | September 28, 2026 |
| [Pennsylvania](https://specstream.ai/data/fda-clearances/state/pennsylvania) | 26 | October 6, 2026 |
| [New York](https://specstream.ai/data/fda-clearances/state/new-york) | 23 | October 23, 2026 |
| [North Carolina](https://specstream.ai/data/fda-clearances/state/north-carolina) | 21 | October 21, 2026 |
| [Georgia](https://specstream.ai/data/fda-clearances/state/georgia) | 17 | September 30, 2026 |
| [Tennessee](https://specstream.ai/data/fda-clearances/state/tennessee) | 16 | March 19, 2026 |
| [Maryland](https://specstream.ai/data/fda-clearances/state/maryland) | 8 | October 14, 2026 |
| Rhode Island | 6 | July 15, 2026 |
| [Ohio](https://specstream.ai/data/fda-clearances/state/ohio) | 4 | September 24, 2026 |
| [Delaware](https://specstream.ai/data/fda-clearances/state/delaware) | 4 | May 22, 2025 |
| [Virginia](https://specstream.ai/data/fda-clearances/state/virginia) | 3 | April 2, 2026 |
| [Missouri](https://specstream.ai/data/fda-clearances/state/missouri) | 3 | October 24, 2025 |
| [New Hampshire](https://specstream.ai/data/fda-clearances/state/new-hampshire) | 3 | September 12, 2025 |

## Where FDA publishes these decisions

- [FDA 510(k) database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm)
- [FDA PMA database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm)
- [openFDA device API](https://open.fda.gov/apis/device/)

Source: [openFDA device 510(k) and PMA (U.S. Food and Drug Administration)](https://open.fda.gov/apis/device/). CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission.

Free to reuse with credit to SpecStream under [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/).