# FDA PMA 135-day supplement decisions: 176 since Nov 2024

Updated October 30, 2026.

FDA made 176 device decisions of type PMA 135-day supplement from November 15, 2024 to October 30, 2026: 0 510(k) clearances and De Novo grants and 176 PMA approvals and supplements, for 59 applicants. The newest, P160035/S054 on October 30, 2026, is EXCOR Pediatric Ventricular Assist Device from Berlin Heart, Inc..

## The full list

FDA PMA 135-day supplement decisions: 176 rows for $8.80, 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 6 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-135-day-supplement

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: 176
- 510(k) and De Novo: 0
- PMA: 176
- Latest decision: October 30, 2026

## Newest decisions

The newest 100 of 176, 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 | P160035/S054 | EXCOR Pediatric Ventricular Assist Device | Berlin Heart, Inc. | Texas | Approved | PMA 135-day supplement | DSQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160035S054) |
| October 19, 2026 | P230013/S029 | Edwards EVOQUE Tricuspid Valve Replacement System | Edwards Lifesciences, LLC | California | Approved | PMA 135-day supplement | NPW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230013S029) |
| October 14, 2026 | P160035/S056 | EXCOR Pediatric VAD | Berlin Heart, Inc. | Texas | Approved | PMA 135-day supplement | DSQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160035S056) |
| October 9, 2026 | P000025/S136 | MED-EL Cochlear Implant System | Med-El Corp. |  | Approved | PMA 135-day supplement | MCM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000025S136) |
| October 1, 2026 | P160035/S057 | EXCOR Pediatric Ventricular Assist Device | Berlin Heart, Inc. | Texas | Approved | PMA 135-day supplement | DSQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160035S057) |
| September 25, 2026 | P230005/S005 | Motiva SmoothSilk® Round and Round Ergonomix® Silicone Gel-Filled Breast Implants | Motiva USA, LLC | California | Approved | PMA 135-day supplement | FTR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230005S005) |
| September 22, 2026 | P220013/S034 | TactiFlex™ Ablation Catheter, Sensor Enabled™ | Abbott Medical | Minnesota | Approved | PMA 135-day supplement | OAE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220013S034) |
| September 18, 2026 | P010032/S251 | Quattrode®; Octrode™; Penta™; Lamitrode™; Tripole™; TriCentrus™ Lead Extensions | Abbott Medical | Texas | Approved | PMA 135-day supplement | LGW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010032S251) |
| September 4, 2026 | P980044/S067 | SUPARTZ FX | Seikagaku Corp. |  | Approved | PMA 135-day supplement | MOZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980044S067) |
| September 4, 2026 | P080020/S056 | Gel-One | Seikagaku Corp. |  | Approved | PMA 135-day supplement | MOZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P080020S056) |
| August 28, 2026 | P130008/S136 | Model 4063 Inspire Stimulation Lead | Inspire Medical Systems | Minnesota | Approved | PMA 135-day supplement | MNQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130008S136) |
| August 28, 2026 | P130008/S123 | INSPIRE II UPPER AIRWAY STIMULATOR | Inspire Medical Systems | Minnesota | Approved | PMA 135-day supplement | MNQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130008S123) |
| August 14, 2026 | P910001/S126 | ELCA Coronary Laser Atherectomy Catheters | Spectranetics Corp. | Colorado | Approved | PMA 135-day supplement | LPC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P910001S126) |
| August 12, 2026 | P190032/S030 | FoundationOne Liquid CDx (F1 Liquid CDx) | Foundation Medicine, Inc. | Massachusetts | Approved | PMA 135-day supplement | PQP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190032S030) |
| August 12, 2026 | P170019/S064 | FoundationOne CDx | Foundation Medicine, Inc. | Massachusetts | Approved | PMA 135-day supplement | PQP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170019S064) |
| August 7, 2026 | P210036/S009 | PerClot® Polysaccharide Hemostatic System | Baxter Healthcare Corporation | Illinois | Approved | PMA 135-day supplement | LMG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P210036S009) |
| August 7, 2026 | P210036/S008 | PerClot® Polysaccharide Hemostatic System | Baxter Healthcare Corporation | Illinois | Approved | PMA 135-day supplement | LMG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P210036S008) |
| August 4, 2026 | P930038/S107 | Angio Seal VIP Vascular Closure Device | Terumo Medical Corporation | Maryland | Approved | PMA 135-day supplement | MGB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P930038S107) |
| August 3, 2026 | P040013/S033 | GEM21S® Growth Factor Enhanced Matrix Implementation of Restricted Access Barrier System (RABS) at Pyramid | Lynch Biologics, LLC | Tennessee | Approved | PMA 135-day supplement | NPZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040013S033) |
| July 31, 2026 | P200041/S005 | Scoreflex NC Scoring PTCA Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. |  | Approved | PMA 135-day supplement | NWX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200041S005) |
| July 31, 2026 | P100044/S059 | Propel, Propel Mini (including Propel Mini with Straight Delivery System), and Propel Contour Sinus Implants | Intersect Ent. | California | Approved | PMA 135-day supplement | OWO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100044S059) |
| July 10, 2026 | P130008/S140 | Model 3150 Implantable Pulse Generator (IPG) | Inspire Medical Systems | Minnesota | Approved | PMA 135-day supplement | MNQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130008S140) |
| June 24, 2026 | P200039/S021 | Shockwave™ lntravascular Lithotripsy (IVL) System with Shockwave C2 / C2+ / C2 Aero/ C2 Aero Fly Coronary IVL... | Shockwave Medical, Inc. | California | Approved | PMA 135-day supplement | QMG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200039S021) |
| June 16, 2026 | P160032/S015 | Defibtech Lifeline; Defibtech Lifeline AUTO; Defibtech Lifeline VIEW; Defibtech Lifeline VIEW AUTO; Defibtech... | Defibtech, LLC | Connecticut | Approved | PMA 135-day supplement | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160032S015) |
| June 11, 2026 | P960030/S084 | UltiPace Low Voltage LPA1231, Tendril Low Voltage 2088TC, OptiSense Low Voltage 1999, Isoflex Low Voltage... | Abbott Medical | California | Approved | PMA 135-day supplement | NVN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960030S084) |
| June 11, 2026 | P960013/S133 | UltiPace Low Voltage LPA1231, Tendril Low Voltage 2088TC, OptiSense Low Voltage 1999, Isoflex Low Voltage... | Abbott Medical | California | Approved | PMA 135-day supplement | NVN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960013S133) |
| June 5, 2026 | P170030/S052 | Orsiro Mission Sirolimus Eluting Coronary Stent System | Biotronik AG |  | Approved | PMA 135-day supplement | NIQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170030S052) |
| June 5, 2026 | P160003/S024 | PRO-Kinetic Energy Coronary Stent System | Biotronik AG |  | Approved | PMA 135-day supplement | MAF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160003S024) |
| June 3, 2026 | P120006/S045 | Alto Abdominal Stent Graft System | Endologix, LLC | California | Approved | PMA 135-day supplement | MIH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P120006S045) |
| May 13, 2026 | P120003/S007 | iCast Covered Stent System | Atrium Medical Corp. | New Hampshire | Approved | PMA 135-day supplement | PRL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P120003S007) |
| May 5, 2026 | P230020/S006 | Altius® Direct Electrical Nerve Stimulation System | Neuros Medical, Inc. | California | Approved | PMA 135-day supplement | SAZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230020S006) |
| May 1, 2026 | P190019/S040 | Ranger™ Paclitaxel-Coated PTA Balloon Catheter | Boston Scientific Corporation | Minnesota | Approved | PMA 135-day supplement | ONU | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190019S040) |
| April 23, 2026 | P120016/S040 | Cardiva, VASCADE Family | Cardiva Medical, Inc. | California | Approved | PMA 135-day supplement | MGB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P120016S040) |
| April 16, 2026 | P960058/S173 | HiResolution Bionic Ear System | Advanced Bionics | California | Approved | PMA 135-day supplement | MCM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960058S173) |
| April 15, 2026 | P170030/S047 | Orsiro Mission Sirolimus Eluting Coronary Stent System | Biotronik AG |  | Approved | PMA 135-day supplement | NIQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170030S047) |
| April 15, 2026 | P160003/S022 | PRO-Kinetic Energy Coronary Stent System | Biotronik AG |  | Approved | PMA 135-day supplement | MAF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160003S022) |
| April 9, 2026 | P140017/S034 | Melody Transcatheter Pulmonary Valve | Medtronic, Inc. | Minnesota | Approved | PMA 135-day supplement | NPV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140017S034) |
| March 31, 2026 | P170002/S053 | RHA® Redensity™ Mepi (also called RHA®1 Mepi), RHA®2 Mepi, RHA®3 Mepi, RHA® Dynamic Volume (formerly called... | Teoxane S.A. |  | Approved | PMA 135-day supplement | LMH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170002S053) |
| March 20, 2026 | P100016/S023 | CT LUCIA 602; CT LUCIA 202; CT LUCIA 611P; CT LUCIA 621P | Carl Zeiss Meditec Production, LLC | California | Approved | PMA 135-day supplement | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100016S023) |
| March 9, 2026 | P190006/S099 | Axonics Sacral Neuromodulation System | Boston Scientific Corporation | Massachusetts | Approved | PMA 135-day supplement | QON | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190006S099) |
| March 9, 2026 | P180046/S099 | Axonics Sacral Neuromodulation System | Boston Scientific Corporation | Massachusetts | Approved | PMA 135-day supplement | EZW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180046S099) |
| March 6, 2026 | P980052/S017 | TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis | Stryker Leibinger, GmbH & Co KG |  | Approved | PMA 135-day supplement | LZD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980052S017) |
| March 4, 2026 | P030016/S051 | The EVO/EVO+ Visian Implantable Collamer Lens (ICL) | STAAR Surgical Company | California | Approved | PMA 135-day supplement | MTA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030016S051) |
| February 19, 2026 | P960030/S080 | IsoFlex | Abbott Medical | California | Approved | PMA 135-day supplement | NVN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960030S080) |
| February 19, 2026 | P960013/S129 | Tendril STS; OptiSense; UltiPace | Abbott Medical | California | Approved | PMA 135-day supplement | NVN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960013S129) |
| February 19, 2026 | P950022/S148 | Durata, Optisure | Abbott Medical | California | Approved | PMA 135-day supplement | LWS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P950022S148) |
| February 19, 2026 | P150035/S026 | Aveir™ VR Leadless Pacemaker, Aveir™ Leadless Pacemaker (Right Ventricular) | Abbott Medical | California | Approved | PMA 135-day supplement | PNJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150035S026) |
| February 19, 2026 | P030054/S435 | Quartet; QuickFlex Micro | Abbott Medical | California | Approved | PMA 135-day supplement | NIK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030054S435) |
| February 18, 2026 | P240039/S002 | SetPoint System | SetPoint Medical | California | Approved | PMA 135-day supplement | SFJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240039S002) |
| February 13, 2026 | P840001/S609 | Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™... | Medtronic Neuromodulation | Minnesota | Approved | PMA 135-day supplement | LGW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P840001S609) |
| February 12, 2026 | P990064/S096 | Mosaic Bioprosthesis | Medtronic, Inc. | California | Approved | PMA 135-day supplement | DYE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990064S096) |
| February 12, 2026 | P980043/S086 | Hancock II Bioprosthesis | Medtronic, Inc. | California | Approved | PMA 135-day supplement | DYE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980043S086) |
| February 12, 2026 | P970031/S078 | Freestyle Bioprosthesis | Medtronic, Inc. | California | Approved | PMA 135-day supplement | LWR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970031S078) |
| February 12, 2026 | P200046/S045 | Harmony Transcatheter Pulmonary Valve | Medtronic, Inc. | California | Approved | PMA 135-day supplement | NPV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200046S045) |
| February 12, 2026 | P170006/S040 | Avalus Bioprostheses | Medtronic, Inc. | California | Approved | PMA 135-day supplement | LWR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170006S040) |
| February 12, 2026 | P140017/S033 | Melody Transcatheter Pulmonary Valve | Medtronic, Inc. | Minnesota | Approved | PMA 135-day supplement | NPV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140017S033) |
| February 12, 2026 | P130021/S179 | Evolut PRO, PRO+, FX, FX+ | Medtronic, Inc. | Minnesota | Approved | PMA 135-day supplement | NPT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130021S179) |
| February 11, 2026 | P970004/S437 | InterStim® Therapy System, Verify® Evaluation System | Medtronic Neuromodulation | Minnesota | Approved | PMA 135-day supplement | EZW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970004S437) |
| February 11, 2026 | P960009/S520 | Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ | Medtronic, Inc. | Minnesota | Approved | PMA 135-day supplement | MHY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960009S520) |
| February 11, 2026 | P840001/S608 | Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and... | Medtronic Neuromodulation | Minnesota | Approved | PMA 135-day supplement | LGW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P840001S608) |
| February 11, 2026 | P080025/S332 | InterStim® Therapy System, Verify® Evaluation System | Medtronic Neuromodulation | Minnesota | Approved | PMA 135-day supplement | QON | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P080025S332) |
| February 11, 2026 | P030017/S387 | Precision Spinal Cord Stimulator (SCS) Systems Introducer Hub Mold Change | Boston Scientific Corp | California | Approved | PMA 135-day supplement | LGW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030017S387) |
| February 6, 2026 | P910001/S124 | ELCA Coronary Atherectomy Catheters | Spectranetics Corp. | Colorado | Approved | PMA 135-day supplement | LPC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P910001S124) |
| January 30, 2026 | P190008/S038 | IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter | Medtronic Vascular, Inc. | California | Approved | PMA 135-day supplement | PRC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190008S038) |
| January 30, 2026 | P140010/S091 | IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT... | Medtronic, Inc. | California | Approved | PMA 135-day supplement | ONU | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140010S091) |
| January 28, 2026 | P240009/S007 | Neuroguard IEP® 3-in-1 Carotid Stent and Post- Dilatation Balloon System with Integrated Embolic Protection | Contego Medical, Inc. | North Carolina | Approved | PMA 135-day supplement | NIM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240009S007) |
| January 23, 2026 | P960058/S170 | HiResolution Bionic Ear System | Advanced Bionics | California | Approved | PMA 135-day supplement | MCM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960058S170) |
| January 22, 2026 | P220021/S007 | DETOUR System | Endologix, LLC | California | Approved | PMA 135-day supplement | QWM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220021S007) |
| January 20, 2026 | P970004/S424 | InterStim TM Therapy System, Verify ™ Evaluation System | Medtronic Neuromodulation | Minnesota | Approved | PMA 135-day supplement | EZW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970004S424) |
| January 20, 2026 | P860004/S443 | SynchroMed ™ Infusion System, Ascenda ® Intrathecal Catheters | Medtronic, Inc. | Minnesota | Approved | PMA 135-day supplement | LKK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P860004S443) |
| January 20, 2026 | P080025/S319 | InterStim TM Therapy System, Verify ™ Evaluation System | Medtronic Neuromodulation | Minnesota | Approved | PMA 135-day supplement | QON | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P080025S319) |
| January 9, 2026 | P100045/S082 | CardioMEMS™ HF System | Abbott Medical | Georgia | Approved | PMA 135-day supplement | MOM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100045S082) |
| January 8, 2026 | P960040/S505 | NG3 Implantable Cardioverter Defibrillators (ICDs): DYNAGEN Models: D020, D021, D022, D023, D150, D151, D152... | Boston Scientific | Minnesota | Approved | PMA 135-day supplement | LWS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960040S505) |
| January 8, 2026 | P150012/S169 | Accolade MRI Pacemakers- ACCOLADE MRI Models: L310, L311, L331; ESSENTIO MRI Models: L110, L111, L131... | Boston Scientific | Minnesota | Approved | PMA 135-day supplement | LWP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150012S169) |
| January 8, 2026 | P110042/S204 | Subcutaneous Implantable Cardioverter Defibrillator (S-ICD): EMBLEM S-ICD Model A209 and EMBLEM MRI S-ICD... | Boston Scientific Corporation | Minnesota | Approved | PMA 135-day supplement | LWS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110042S204) |
| January 8, 2026 | P070026/S118 | Ceramax® Ceramic Total Hip System | DePuy Orthopaedics, Inc. | Indiana | Approved | PMA 135-day supplement | MRA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P070026S118) |
| January 8, 2026 | P030005/S247 | Accolade CRT – Pacemakers (CRT-Ps): VALITUDE CRT-P U125; VALITUDE X4 CRT-P Model U128; VISIONIST CRT-P Models... | Guidant Corp. | Minnesota | Approved | PMA 135-day supplement | NKE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030005S247) |
| January 8, 2026 | P010012/S592 | NG3 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds): DYNAGEN Models: G150, G151, G154, G156, G158... | Boston Scientific Corp | Minnesota | Approved | PMA 135-day supplement | NIK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010012S592) |
| January 8, 2026 | N970003/S301 | Accolade Pacemakers: ACCOLADE Models: L300, L301, L321; ALTRUA 2 Models: S701, S702, S722; ESSENTIO Models... | Boston Scientific Corp | Minnesota | Approved | PMA 135-day supplement | LWP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=N970003S301) |
| December 31, 2025 | P000057/S013 | Ascension MCP | Smith & Nephew, Inc. | Tennessee | Approved | PMA 135-day supplement | NEG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000057S013) |
| November 20, 2025 | P190009/S006 | OPRA Implant System, Abutment component | Integrum AB |  | Approved | PMA 135-day supplement | PJY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190009S006) |
| November 20, 2025 | P070004/S045 | Sientra Silicone Gel Breast Implants | Tiger Aesthetics Medical, LLC | Wisconsin | Approved | PMA 135-day supplement | FTR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P070004S045) |
| November 19, 2025 | P180036/S034 | OPTIMIZER SMART Mini IPG | Impulse Dynamics (Usa), Inc. | New Jersey | Approved | PMA 135-day supplement | QFV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180036S034) |
| November 18, 2025 | P990075/S065 | MENTOR™ Saline-Filled and SPECTRUM™ Breast Implants | Mentor Worldwide, LLC | California | Approved | PMA 135-day supplement | FWM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990075S065) |
| November 12, 2025 | P200007/S001 | HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads | Graphic Controls D.B.A. Vermed | New York | Approved | PMA 135-day supplement | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200007S001) |
| November 6, 2025 | P130014/S021 | Adherus AutoSpray Dural Sealant | Stryker Leibinger GmbH & Co KG |  | Approved | PMA 135-day supplement | NQR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130014S021) |
| October 24, 2025 | P950037/S272 | 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 | Approved | PMA 135-day supplement | DXY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P950037S272) |
| October 24, 2025 | P070008/S167 | Edora 8 HF-T QP; Edora 8 HF-T; Evity 8 HF-T QP; Evity 8 HF-T; Enitra 8 HF-T QP; Enitra 8 HF-T; Enticos 8 HF-T... | Biotronik, Inc. | Oregon | Approved | PMA 135-day supplement | NKE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P070008S167) |
| October 24, 2025 | P050023/S196 | Acticor 7 VR-T; Rivacor 7 VR-T; Rivacor 5 VR-T; Rivacor 3 VR-T; Acticor 7 VR-T DX; Rivacor 7 VR-T DX; Rivacor... | Biotronik, Inc. | Oregon | Approved | PMA 135-day supplement | MRM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P050023S196) |
| October 17, 2025 | P160054/S094 | HeartMate 3 Left Ventricular Assist System, HeartMate II Left Ventricular Assist System | Abbott Medical | California | Approved | PMA 135-day supplement | DSQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160054S094) |
| October 17, 2025 | P060040/S112 | HeartMate Apical Coring Knife | Abbott Medical | California | Approved | PMA 135-day supplement | DSQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P060040S112) |
| October 10, 2025 | P170030/S056 | Orsiro Mission Sirolimus Eluting Coronary Stent System | Biotronik AG |  | Approved | PMA 135-day supplement | NIQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170030S056) |
| October 6, 2025 | P160054/S104 | HeartMate 3™ Left Ventricular Assist System | Abbott Medical | California | Approved | PMA 135-day supplement | DSQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160054S104) |
| October 2, 2025 | P170008/S056 | EluNIR™ Ridaforolimus Eluting Coronary Stent System | Medinol, Ltd. |  | Approved | PMA 135-day supplement | NIQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170008S056) |
| September 18, 2025 | P010052/S020 | IMMULITE 2000 Total Antibodies to Hepatitis B Surface Antigen (Anti-HBs) | Siemens Healthcare Diagnostics Products, Ltd. |  | Approved | PMA 135-day supplement | LOM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010052S020) |
| September 18, 2025 | P010050/S026 | IMMULITE 2000 Hepatitis B Surface Antigen (HBsAg), IMMULITE 2000 Hepatitis B Surface Antigen (HBsAg)... | Siemens Healthcare Diagnostics Products, Ltd. |  | Approved | PMA 135-day supplement | LOM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010050S026) |
| September 18, 2025 | P010050/S025 | IMMULITE 2000 Hepatitis B Surface Antigen (HBsAg), IMMULITE 2000 Hepatitis B Surface Antigen (HBsAg)... | Siemens Healthcare Diagnostics Products, Ltd. |  | Approved | PMA 135-day supplement | LOM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010050S025) |
| September 10, 2025 | P970004/S421 | InterStim® Therapy System | Medtronic Neuromodulation | Minnesota | Approved | PMA 135-day supplement | EZW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970004S421) |
| September 10, 2025 | P080025/S316 | InterStim® Therapy System | Medtronic Neuromodulation | Minnesota | Approved | PMA 135-day supplement | QON | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P080025S316) |
| August 22, 2025 | P960004/S106 | FINELINE® II EZ Sterox | Boston Scientific | Minnesota | Approved | PMA 135-day supplement | NVN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960004S106) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Medtronic, Inc. | 37 | April 9, 2026 |
| Abbott Medical | 15 | September 22, 2026 |
| Medtronic Neuromodulation | 14 | February 13, 2026 |
| Medtronic Cardiac Rhythm Disease Management | 9 | June 5, 2025 |
| Boston Scientific Corporation | 8 | May 1, 2026 |
| Biotronik AG | 6 | June 5, 2026 |
| Boston Scientific Corp | 5 | February 11, 2026 |
| Boston Scientific | 5 | January 8, 2026 |
| Berlin Heart, Inc. | 4 | October 30, 2026 |
| Inspire Medical Systems | 4 | August 28, 2026 |
| Spectranetics Corp. | 3 | August 14, 2026 |
| Baxter Healthcare Corporation | 3 | August 7, 2026 |
| Mentor Worldwide, LLC | 3 | November 18, 2025 |
| Biotronik, Inc. | 3 | October 24, 2025 |
| Siemens Healthcare Diagnostics Products, Ltd. | 3 | September 18, 2025 |
| Seikagaku Corp. | 2 | September 4, 2026 |
| Foundation Medicine, Inc. | 2 | August 12, 2026 |
| Endologix, LLC | 2 | June 3, 2026 |
| Advanced Bionics | 2 | April 16, 2026 |
| Teoxane S.A. | 2 | March 31, 2026 |

## By panel

| Panel | Decisions | Latest |
| --- | --- | --- |
| [Cardiovascular](https://specstream.ai/data/fda-clearances/panel/cardiovascular) | 104 | October 30, 2026 |
| [Gastroenterology, Urology](https://specstream.ai/data/fda-clearances/panel/gastroenterology-urology) | 15 | March 9, 2026 |
| [General, Plastic Surgery](https://specstream.ai/data/fda-clearances/panel/general-plastic-surgery) | 14 | September 25, 2026 |
| [Neurology](https://specstream.ai/data/fda-clearances/panel/neurology) | 12 | September 18, 2026 |
| [Orthopedic](https://specstream.ai/data/fda-clearances/panel/orthopedic) | 8 | September 4, 2026 |
| [Anesthesiology](https://specstream.ai/data/fda-clearances/panel/anesthesiology) | 5 | August 28, 2026 |
| [Ophthalmic](https://specstream.ai/data/fda-clearances/panel/ophthalmic) | 5 | March 20, 2026 |
| [Ear, Nose, Throat](https://specstream.ai/data/fda-clearances/panel/ear-nose-throat) | 4 | October 9, 2026 |
| [Microbiology](https://specstream.ai/data/fda-clearances/panel/microbiology) | 3 | September 18, 2025 |
| [Pathology](https://specstream.ai/data/fda-clearances/panel/pathology) | 2 | August 12, 2026 |
| [Dental](https://specstream.ai/data/fda-clearances/panel/dental) | 2 | August 3, 2026 |
| [General Hospital](https://specstream.ai/data/fda-clearances/panel/general-hospital) | 2 | January 20, 2026 |

## By state or country

| State or country | Decisions | Latest |
| --- | --- | --- |
| [Minnesota](https://specstream.ai/data/fda-clearances/state/minnesota) | 70 | September 22, 2026 |
| [California](https://specstream.ai/data/fda-clearances/state/california) | 45 | October 19, 2026 |
| [Massachusetts](https://specstream.ai/data/fda-clearances/state/massachusetts) | 8 | August 12, 2026 |
| [Texas](https://specstream.ai/data/fda-clearances/state/texas) | 5 | October 30, 2026 |
| [Illinois](https://specstream.ai/data/fda-clearances/state/illinois) | 4 | August 7, 2026 |
| [New Jersey](https://specstream.ai/data/fda-clearances/state/new-jersey) | 4 | November 19, 2025 |
| [Oregon](https://specstream.ai/data/fda-clearances/state/oregon) | 3 | October 24, 2025 |
| [Colorado](https://specstream.ai/data/fda-clearances/state/colorado) | 2 | August 14, 2026 |
| [Tennessee](https://specstream.ai/data/fda-clearances/state/tennessee) | 2 | August 3, 2026 |
| [Indiana](https://specstream.ai/data/fda-clearances/state/indiana) | 2 | January 8, 2026 |
| [New York](https://specstream.ai/data/fda-clearances/state/new-york) | 2 | November 12, 2025 |
| [Pennsylvania](https://specstream.ai/data/fda-clearances/state/pennsylvania) | 2 | June 5, 2025 |
| [Maryland](https://specstream.ai/data/fda-clearances/state/maryland) | 1 | August 4, 2026 |
| [Connecticut](https://specstream.ai/data/fda-clearances/state/connecticut) | 1 | June 16, 2026 |
| [New Hampshire](https://specstream.ai/data/fda-clearances/state/new-hampshire) | 1 | May 13, 2026 |
| [North Carolina](https://specstream.ai/data/fda-clearances/state/north-carolina) | 1 | January 28, 2026 |
| [Georgia](https://specstream.ai/data/fda-clearances/state/georgia) | 1 | January 9, 2026 |
| [Wisconsin](https://specstream.ai/data/fda-clearances/state/wisconsin) | 1 | November 20, 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/).