# FDA PMA 180-day supplement decisions: 721 since Nov 2024

Updated October 30, 2026.

FDA made 721 device decisions of type PMA 180-day supplement from November 13, 2024 to October 30, 2026: 0 510(k) clearances and De Novo grants and 721 PMA approvals and supplements, for 203 applicants. The newest, P250025/S002 on October 30, 2026, is TorEx Lung Perfusion System; TorEx Lung Perfusate from Traferox Technologies, Inc..

## The full list

FDA PMA 180-day supplement decisions: 721 rows for $36.05, 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 35 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-180-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: 721
- 510(k) and De Novo: 0
- PMA: 721
- Latest decision: October 30, 2026

## Newest decisions

The newest 100 of 721, 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 | P250025/S002 | TorEx Lung Perfusion System; TorEx Lung Perfusate | Traferox Technologies, Inc. |  | Approved | PMA 180-day supplement | PHO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250025S002) |
| October 30, 2026 | P250025/S001 | TorEx Lung Perfusion System; TorEx Lung Perfusate | Traferox Technologies, Inc. |  | Approved | PMA 180-day supplement | PHO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250025S001) |
| October 30, 2026 | P190018/S050 | Clareon Vivity Pro Extended Vision IOLs | Alcon Laboratories, LLC | Texas | Approved | PMA 180-day supplement | POE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190018S050) |
| October 29, 2026 | P230040/S030 | Cordella Pulmonary Artery Sensor System | Endotronix, Inc. | Illinois | Approved | PMA 180-day supplement | MOM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230040S030) |
| October 29, 2026 | P190023/S033 | Navitor Transcatheter Aortic Valve Implantation System | Abbott Medical | Minnesota | Approved | PMA 180-day supplement | NPT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190023S033) |
| October 27, 2026 | P860004/S458 | SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters | Medtronic, Inc. | Minnesota | Approved | PMA 180-day supplement | LKK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P860004S458) |
| October 27, 2026 | P200015/S077 | SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra C Adaptive Prestent | Edwards Lifesciences, LLC | California | Approved | PMA 180-day supplement | NPV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200015S077) |
| October 24, 2026 | P180031/S012 | Neuroform Atlas® Stent System | Stryker Neurovascular | California | Approved | PMA 180-day supplement | QCA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180031S012) |
| October 23, 2026 | P990040/S037 | TRUFILL n-BCA Liquid Embolic System | Cerenovus, Inc. | Florida | Approved | PMA 180-day supplement | KGG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990040S037) |
| October 23, 2026 | P240037/S003 | VENTANA MET (SP44) RxDx Assay | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | Arizona | Approved | PMA 180-day supplement | SER | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240037S003) |
| October 23, 2026 | P220024/S007 | LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation (HMF) Device; LIQUIFIX Precision Open Hernia Mesh Fixation... | Advanced Medical Solutions Limited |  | Approved | PMA 180-day supplement | PLJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220024S007) |
| October 23, 2026 | P200020/S013 | ClearView™ HD intraocular lens (IOL) | Lenstec, Inc. | Florida | Approved | PMA 180-day supplement | MFK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200020S013) |
| October 22, 2026 | P150048/S100 | INSPIRIS RESILIA Aortic Valve; MITRIS RESILIA Mitral Valve | Edwards Lifesciences, LLC | California | Approved | PMA 180-day supplement | LWR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150048S100) |
| October 22, 2026 | P140031/S202 | Edwards SAPIEN 3 Ultra™ RESILIA Transcatheter Heart Valve | Edwards Lifesciences, LLC | California | Approved | PMA 180-day supplement | NPT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140031S202) |
| October 21, 2026 | P150035/S042 | AVEIR VR Real-World Evidence Study | Abbott Medical | California | Approved | PMA 180-day supplement | PNJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150035S042) |
| October 16, 2026 | P950037/S289 | BIOexpress | Biotronik, Inc. | Oregon | Approved | PMA 180-day supplement | DXY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P950037S289) |
| October 16, 2026 | P250009/S001 | SQUID Liquid Embolic Agent (LEA) | Balt USA, LLC | California | Approved | PMA 180-day supplement | SGU | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250009S001) |
| October 16, 2026 | P240033/S002 | LungFX™ Device | Lung Bioengineering, Inc. | Maryland | Approved | PMA 180-day supplement | PHO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240033S002) |
| October 16, 2026 | P240033/S001 | LungFX™ Device | Lung Bioengineering, Inc. | Maryland | Approved | PMA 180-day supplement | PHO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240033S001) |
| October 16, 2026 | P160015/S029 | AED 3 Defibrillator with Uni-Padz | ZOLL Medical Corporation | Massachusetts | Approved | PMA 180-day supplement | MKJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160015S029) |
| October 16, 2026 | P070008/S177 | BIOexpress | Biotronik, Inc. | Oregon | Approved | PMA 180-day supplement | NKE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P070008S177) |
| October 16, 2026 | P050023/S209 | BIOexpress | Biotronik, Inc. | Oregon | Approved | PMA 180-day supplement | MRM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P050023S209) |
| October 16, 2026 | P000009/S128 | BIOexpress | Biotronik, Inc. | Oregon | Approved | PMA 180-day supplement | MRM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000009S128) |
| October 15, 2026 | P250022/S002 | Volt™ PFA System | Abbott Medical | Minnesota | Approved | PMA 180-day supplement | QZI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250022S002) |
| October 14, 2026 | P030004/S039 | Onyx™ Liquid Embolic System (Onyx™ LES) | Ev3 Neurovascular | California | Approved | PMA 180-day supplement | MFE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030004S039) |
| October 9, 2026 | P200035/S038 | OrganOx metra® System | Organox Limited |  | Approved | PMA 180-day supplement | QQK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200035S038) |
| October 8, 2026 | P250021/S002 | saypha® ChiQ™ | Croma-Pharma GmbH |  | Approved | PMA 180-day supplement | LMH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250021S002) |
| October 8, 2026 | P210001/S016 | VENTANA MMR RxDx Panel | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | Arizona | Approved | PMA 180-day supplement | QNH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P210001S016) |
| October 8, 2026 | P200019/S014 | VENTANA MMR RxDx Panel | Ventana Medical Systems | Arizona | Approved | PMA 180-day supplement | QNH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200019S014) |
| October 7, 2026 | P250021/S001 | saypha® ChiQ™ | Croma-Pharma GmbH |  | Approved | PMA 180-day supplement | LMH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250021S001) |
| October 2, 2026 | P230005/S002 | Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk Round Silicone... | Motiva USA, LLC | California | Approved | PMA 180-day supplement | FTR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230005S002) |
| October 1, 2026 | P220014/S013 | CraniSeal™ Dural Sealant | Pramand, LLC | Massachusetts | Approved | PMA 180-day supplement | NQR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220014S013) |
| September 29, 2026 | P160017/S140 | MiniMed 780G System | Medtronic Minimed, Inc. | California | Approved | PMA 180-day supplement | OZP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160017S140) |
| September 29, 2026 | P020056/S064 | Natrelle Silicone-Filled Breast Implants and Natrelle INSPIRA Silicone-Filled Breast Implants | Allergan | California | Approved | PMA 180-day supplement | FTR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P020056S064) |
| September 28, 2026 | P850064/S056 | LifePulse® High Frequency Ventilator | Bunnell, Inc. | Utah | Approved | PMA 180-day supplement | LSZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P850064S056) |
| September 25, 2026 | P980023/S140 | Ilivia Neo 7 VR-T DX 429530; Intica Neo 7 VR-T DX 429559; Intica Neo 5 VR-T DX 429569 | Biotronik, Inc. | Oregon | Approved | PMA 180-day supplement | LWS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980023S140) |
| September 25, 2026 | P950037/S279 | Edora 8 DR-T 407145, Evity 8 DR-T 407146, Enitra 8 DR-T 407147, Enticos 8 DR-T 407148, Evity 6 DR-T 407149... | Biotronik, Inc. | Oregon | Approved | PMA 180-day supplement | DXY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P950037S279) |
| September 25, 2026 | P100010/S154 | STOP Persistent AF | Medtronic Cryocath, LP | Minnesota | Approved | PMA 180-day supplement | OAE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100010S154) |
| September 25, 2026 | P070008/S172 | Edora 8 HF-T QP 407137 Edora 8 HF-T 407138 Evity 8 HF-T QP 407139 Evity 8 HF-T 407140 Enitra 8 HF-T QP 407141... | Biotronik, Inc. | Oregon | Approved | PMA 180-day supplement | NKE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P070008S172) |
| September 25, 2026 | P050023/S204 | Ilivia 7 VR-T DX 404624; Intica 7 VR-T DX 404633; Intica 5 VR-T DX 404688; Ilivia 7 VR-T 404625; Intica 7... | Biotronik, Inc. | Oregon | Approved | PMA 180-day supplement | MRM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P050023S204) |
| September 25, 2026 | P000009/S124 | Ilivia Neo 7 DR-T 429529; Intica Neo 7 DR-T 429558; Intica Neo 5 DR-T 429568 | Biotronik, Inc. | Oregon | Approved | PMA 180-day supplement | MRM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000009S124) |
| September 23, 2026 | P250023/S002 | Allurion™ Gastric Balloon System | Allurion Technologies, Inc. | Massachusetts | Approved | PMA 180-day supplement | LTI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250023S002) |
| September 23, 2026 | P220003/S028 | PASCAL Ace with Capture Clarity™ Valve Repair System – MR Implant System | Edwards Lifesciences, LLC | California | Approved | PMA 180-day supplement | NKM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220003S028) |
| September 22, 2026 | P250042/S002 | BAGUERA®C Cervical Disc Prosthesis | Spineart USA, Inc. | California | Approved | PMA 180-day supplement | MJO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250042S002) |
| September 21, 2026 | P830055/S351 | Attune Revision Knee System | Depuy, Inc. | Indiana | Approved | PMA 180-day supplement | NJL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P830055S351) |
| September 21, 2026 | P250033/S004 | NEXUS Aortic Arch Stent Graft System | Endospan , Ltd. | Wyoming | Approved | PMA 180-day supplement | SDZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250033S004) |
| September 18, 2026 | P990004/S080 | SURGIFOAM® Absorbable Gelatin Sponge | Ferrosan Meidcal Devices A/S |  | Approved | PMA 180-day supplement | LMF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990004S080) |
| September 18, 2026 | P960058/S178 | CLARION MULTI-STRATEGY COCHLEAR IMPLANT | Advanced Bionics | California | Approved | PMA 180-day supplement | MCM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960058S178) |
| September 18, 2026 | P200010/S029 | Guardant360 CDx | Guardant Health, Inc. | California | Approved | PMA 180-day supplement | PQP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200010S029) |
| September 18, 2026 | P140029/S058 | Restylane® Contour | Q-Med AB |  | Approved | PMA 180-day supplement | LMH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140029S058) |
| September 18, 2026 | P100034/S045 | Novocure GmbH’s Optune Gio | Novocure, GmbH |  | Approved | PMA 180-day supplement | NZK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100034S045) |
| September 16, 2026 | P230013/S027 | EVOQUE Tricuspid Valve Replacement System | Edwards Lifesciences, LLC | California | Approved | PMA 180-day supplement | NPW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230013S027) |
| September 16, 2026 | P170019/S069 | FoundationOne CDx | Foundation Medicine, Inc. | Massachusetts | Approved | PMA 180-day supplement | PQP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170019S069) |
| September 16, 2026 | P150038/S044 | Exablate Model 4000 System | Insightec |  | Approved | PMA 180-day supplement | POH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150038S044) |
| September 15, 2026 | P230016/S003 | MAGE-A4 IHC 1F9 pharmDx | Agilent Technologies, Inc. | California | Approved | PMA 180-day supplement | SBL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230016S003) |
| September 13, 2026 | P150031/S084 | VERCISE DEEP BRAIN STIMULATION (DBS) SYSTEM | Boston Scientific Corp | California | Approved | PMA 180-day supplement | NHL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150031S084) |
| September 10, 2026 | P220026/S014 | Symplicity Spyral™ Renal Denervation System | Medtronic, Inc. | California | Approved | PMA 180-day supplement | QYI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220026S014) |
| September 9, 2026 | P070001/S031 | prodisc® C Nova | Centinel Spine, LLC | Pennsylvania | Approved | PMA 180-day supplement | MJO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P070001S031) |
| September 9, 2026 | P030017/S396 | WaveWriter Alpha™ and WaveWriter Alpha™ Prime SCS Systems; Celestia and Celestia Prime SCS Systems | Boston Scientific Corp | California | Approved | PMA 180-day supplement | LGW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030017S396) |
| September 8, 2026 | P210006/S018 | Thoraflex™ Hybrid | Vascutek, Ltd. |  | Approved | PMA 180-day supplement | QSK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P210006S018) |
| September 4, 2026 | P200010/S024 | Guardant360® CDx | Guardant Health, Inc. | California | Approved | PMA 180-day supplement | PQP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200010S024) |
| September 3, 2026 | P170012/S032 | HEMOBLAST™ Bellows | Dilon Technologies, Inc. | Virginia | Approved | PMA 180-day supplement | PMX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170012S032) |
| September 2, 2026 | P210011/S002 | xT CDx | Tempus AI, Inc. | Illinois | Approved | PMA 180-day supplement | PQP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P210011S002) |
| September 2, 2026 | P030031/S142 | THERMOCOOL SMARTTOUCH® SF Catheter | Biosense Webster, Inc. | California | Approved | PMA 180-day supplement | OAD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030031S142) |
| September 1, 2026 | P160035/S058 | EXCOR Pediatric Ventricular Assist Device | Berlin Heart, Inc. | Texas | Approved | PMA 180-day supplement | DSQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160035S058) |
| August 31, 2026 | P250016/S004 | Belotero® Intense (+) Lidocaine | Merz North America, Inc. | North Carolina | Approved | PMA 180-day supplement | LMH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250016S004) |
| August 27, 2026 | P240035/S004 | ETHIZIA™ Hemostatic Patch | ETHICON, Inc. | New Jersey | Approved | PMA 180-day supplement | SGV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240035S004) |
| August 27, 2026 | P240003/S008 | Minima Stent System; Minima Pro Stent System | Renata Medical, Inc. | California | Approved | PMA 180-day supplement | PNF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240003S008) |
| August 27, 2026 | P230001/S012 | ColoSense® | Geneoscopy, Inc. | Missouri | Approved | PMA 180-day supplement | SBB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230001S012) |
| August 27, 2026 | P180047/S043 | LIAISON QuantiFERON-TB Gold Plus; LIAISON XL Control QuantiFERON-TB Gold Plus; LIAISON QuantiFERON-TB Gold... | DiaSorin, Inc. | Minnesota | Approved | PMA 180-day supplement | NCD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180047S043) |
| August 27, 2026 | P150035/S041 | Aveir VR Leadless System | Abbott Medical | California | Approved | PMA 180-day supplement | PNJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150035S041) |
| August 26, 2026 | P240021/S001 | Atellica IM Total PSA II (tPSAII) | Siemens Healthcare Diagnostics, Inc. | New York | Approved | PMA 180-day supplement | MTF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240021S001) |
| August 26, 2026 | P050053/S066 | INFUSE BONE GRAFT | Medtronic, Inc. | Tennessee | Approved | PMA 180-day supplement | NPZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P050053S066) |
| August 26, 2026 | P000058/S095 | INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE | Medtronic Sofamor Danek USA, Inc. | Tennessee | Approved | PMA 180-day supplement | NEK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000058S095) |
| August 26, 2026 | P000054/S075 | INFUSE BONE GRAFT | Medtronic Sofamor Danek USA, Inc. | Tennessee | Approved | PMA 180-day supplement | MPW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000054S075) |
| August 25, 2026 | P230030/S016 | FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter... | Farapulse, Inc. | California | Approved | PMA 180-day supplement | QZI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230030S016) |
| August 21, 2026 | P200029/S014 | TheraSphere | Boston Scientific Corporation | Massachusetts | Approved | PMA 180-day supplement | NAW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200029S014) |
| August 20, 2026 | P180007/S016 | Spiration® Valve System | Gyrus Acmi, Inc. | Washington | Approved | PMA 180-day supplement | NJK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180007S016) |
| August 19, 2026 | P160037/S027 | BD Onclarity HPV Assay Reagent Pack (SKU 444075) and BD COR™ HPV Extraction Trough (SKU 444074) | Becton, Dickinson and Company | Maryland | Approved | PMA 180-day supplement | MAQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160037S027) |
| August 18, 2026 | P220034/S010 | LIAISON Biotrin Parvovirus B19 IgG Plus; LIAISON Biotrin Control Parvovirus B19 IgG Plus | DiaSorin, Inc. | Minnesota | Approved | PMA 180-day supplement | MYL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220034S010) |
| August 18, 2026 | P130022/S069 | HFX Dynamis System | Nevro Corporation | California | Approved | PMA 180-day supplement | LGW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130022S069) |
| August 17, 2026 | P190018/S051 | Clareon Aspheric Hydrophobic Acrylic Intraocular Lens with the AutonoMe Pre- Loaded Delivery System, Clareon... | Alcon Laboratories, LLC | Texas | Approved | PMA 180-day supplement | HQL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190018S051) |
| August 13, 2026 | P220023/S011 | Paradise™ Ultrasound Renal Denervation System (Paradise System) | Recor Medical, Inc. | California | Approved | PMA 180-day supplement | QYI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220023S011) |
| August 12, 2026 | P970003/S249 | VNS Therapy System | LivaNova USA, Inc. | Texas | Approved | PMA 180-day supplement | LYJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970003S249) |
| August 11, 2026 | P110033/S091 | Juvéderm Voluma XC, Vollure XC, Volbella XC, Volux XC, Skinvive | Allergan | California | Approved | PMA 180-day supplement | LMH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110033S091) |
| August 11, 2026 | P050047/S098 | Ultra, Ultra XC, Ultra Plus XC | Allergan | California | Approved | PMA 180-day supplement | LMH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P050047S098) |
| August 10, 2026 | P250008/S001 | Claire™ OCT System | Perimeter Medical Imaging Ai, Inc. |  | Approved | PMA 180-day supplement | SHH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250008S001) |
| August 7, 2026 | P200010/S032 | Guardant360® CDx | Guardant Health, Inc. | California | Approved | PMA 180-day supplement | PQP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200010S032) |
| August 7, 2026 | P190006/S113 | Axonics Sacral Neuromodulation System | Boston Scientific Corporation | Massachusetts | Approved | PMA 180-day supplement | QON | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190006S113) |
| August 7, 2026 | P180046/S113 | Axonics Sacral Neuromodulation System | Boston Scientific Corporation | Massachusetts | Approved | PMA 180-day supplement | EZW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180046S113) |
| August 7, 2026 | P170030/S065 | ORSIRO Sirolimus Eluting Coronary Stent System | Biotronik AG |  | Approved | PMA 180-day supplement | NIQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170030S065) |
| August 7, 2026 | P020012/S051 | SANAE® | Tiger Aesthetics Medical, LLC | Pennsylvania | Approved | PMA 180-day supplement | LMH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P020012S051) |
| August 6, 2026 | P230030/S018 | FARAPULSE™ Pulsed Field Ablation System | Farapulse, Inc. | California | Approved | PMA 180-day supplement | QZI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230030S018) |
| August 6, 2026 | P100010/S152 | Stop AF First | Medtronic Cryocath, LP | Minnesota | Approved | PMA 180-day supplement | OAE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100010S152) |
| August 5, 2026 | P830055/S360 | ATTUNE Revision Knee System | Depuy, Inc. | Indiana | Approved | PMA 180-day supplement | NJL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P830055S360) |
| August 5, 2026 | P100047/S240 | HeartWare™ HVAD™ System | Medtronic | Minnesota | Approved | PMA 180-day supplement | DSQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100047S240) |
| August 5, 2026 | P030004/S042 | Onyx™ Liquid Embolic System (LES) | Ev3 Neurovascular | California | Approved | PMA 180-day supplement | SGU | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030004S042) |
| August 4, 2026 | P890047/S070 | PROVISC Ophthalmic Viscosurgical Device | Alcon Research, Ltd. | Texas | Approved | PMA 180-day supplement | LZP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P890047S070) |
| August 4, 2026 | P840064/S092 | VISCOAT Ophthalmic Viscosurgical Device; DUOVISC Ophthalmic Viscoelastic System. | Alcon Laboratories | Texas | Approved | PMA 180-day supplement | LZP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P840064S092) |
| August 4, 2026 | P190019/S043 | Ranger™ Paclitaxel-Coated Balloon Catheter | Boston Scientific Corporation | Minnesota | Approved | PMA 180-day supplement | ONU | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190019S043) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Abbott Medical | 84 | October 29, 2026 |
| Medtronic, Inc. | 36 | October 27, 2026 |
| Boston Scientific Corporation | 27 | August 21, 2026 |
| Edwards Lifesciences, LLC | 23 | October 27, 2026 |
| Biotronik, Inc. | 22 | October 16, 2026 |
| Boston Scientific Corp | 20 | September 13, 2026 |
| Biosense Webster, Inc. | 13 | September 2, 2026 |
| Medtronic Neuromodulation | 12 | July 13, 2026 |
| W. L. Gore & Associates, Inc. | 12 | July 13, 2026 |
| ZOLL Medical Corporation | 10 | October 16, 2026 |
| Foundation Medicine, Inc. | 10 | September 16, 2026 |
| Boston Scientific | 10 | April 21, 2026 |
| Medtronic | 8 | August 5, 2026 |
| Ventana Medical Systems, Inc. | 8 | May 15, 2026 |
| Abiomed, Inc. | 8 | September 15, 2025 |
| Allergan | 7 | September 29, 2026 |
| CooperVision, Inc. | 7 | December 17, 2025 |
| MicroPort CRM S.r.l. | 7 | November 25, 2025 |
| Guardant Health, Inc. | 6 | September 18, 2026 |
| Medtronic Cardiac Rhythm Disease Management | 6 | May 28, 2026 |

## By panel

| Panel | Decisions | Latest |
| --- | --- | --- |
| [Cardiovascular](https://specstream.ai/data/fda-clearances/panel/cardiovascular) | 333 | October 29, 2026 |
| [Neurology](https://specstream.ai/data/fda-clearances/panel/neurology) | 63 | October 24, 2026 |
| [Gastroenterology, Urology](https://specstream.ai/data/fda-clearances/panel/gastroenterology-urology) | 50 | October 30, 2026 |
| [Pathology](https://specstream.ai/data/fda-clearances/panel/pathology) | 47 | October 23, 2026 |
| [Ophthalmic](https://specstream.ai/data/fda-clearances/panel/ophthalmic) | 45 | October 30, 2026 |
| [General, Plastic Surgery](https://specstream.ai/data/fda-clearances/panel/general-plastic-surgery) | 45 | October 23, 2026 |
| [Orthopedic](https://specstream.ai/data/fda-clearances/panel/orthopedic) | 42 | September 22, 2026 |
| [Microbiology](https://specstream.ai/data/fda-clearances/panel/microbiology) | 26 | August 27, 2026 |
| [Anesthesiology](https://specstream.ai/data/fda-clearances/panel/anesthesiology) | 12 | September 28, 2026 |
| [Ear, Nose, Throat](https://specstream.ai/data/fda-clearances/panel/ear-nose-throat) | 11 | September 18, 2026 |
| [Clinical Chemistry](https://specstream.ai/data/fda-clearances/panel/clinical-chemistry) | 10 | September 29, 2026 |
| [Immunology](https://specstream.ai/data/fda-clearances/panel/immunology) | 8 | August 26, 2026 |
| [General Hospital](https://specstream.ai/data/fda-clearances/panel/general-hospital) | 6 | October 27, 2026 |
| [Radiology](https://specstream.ai/data/fda-clearances/panel/radiology) | 6 | August 21, 2026 |
| [Dental](https://specstream.ai/data/fda-clearances/panel/dental) | 5 | August 26, 2026 |
| [Medical Genetics](https://specstream.ai/data/fda-clearances/panel/medical-genetics) | 4 | July 22, 2026 |
| [Obstetrics/Gynecology](https://specstream.ai/data/fda-clearances/panel/obstetrics-gynecology) | 4 | July 13, 2026 |
| [Clinical Toxicology](https://specstream.ai/data/fda-clearances/panel/clinical-toxicology) | 2 | May 20, 2026 |
| [Physical Medicine](https://specstream.ai/data/fda-clearances/panel/physical-medicine) | 2 | February 26, 2026 |

## By state or country

| State or country | Decisions | Latest |
| --- | --- | --- |
| [California](https://specstream.ai/data/fda-clearances/state/california) | 229 | October 27, 2026 |
| [Minnesota](https://specstream.ai/data/fda-clearances/state/minnesota) | 130 | October 29, 2026 |
| [Massachusetts](https://specstream.ai/data/fda-clearances/state/massachusetts) | 58 | October 16, 2026 |
| [Texas](https://specstream.ai/data/fda-clearances/state/texas) | 35 | October 30, 2026 |
| [Arizona](https://specstream.ai/data/fda-clearances/state/arizona) | 32 | October 23, 2026 |
| [Oregon](https://specstream.ai/data/fda-clearances/state/oregon) | 24 | October 16, 2026 |
| [Florida](https://specstream.ai/data/fda-clearances/state/florida) | 13 | October 23, 2026 |
| [New York](https://specstream.ai/data/fda-clearances/state/new-york) | 13 | August 26, 2026 |
| [Indiana](https://specstream.ai/data/fda-clearances/state/indiana) | 12 | September 21, 2026 |
| [Maryland](https://specstream.ai/data/fda-clearances/state/maryland) | 11 | October 16, 2026 |
| [Colorado](https://specstream.ai/data/fda-clearances/state/colorado) | 11 | April 9, 2026 |
| [Pennsylvania](https://specstream.ai/data/fda-clearances/state/pennsylvania) | 10 | September 9, 2026 |
| [Tennessee](https://specstream.ai/data/fda-clearances/state/tennessee) | 10 | August 26, 2026 |
| [Illinois](https://specstream.ai/data/fda-clearances/state/illinois) | 9 | October 29, 2026 |
| [New Jersey](https://specstream.ai/data/fda-clearances/state/new-jersey) | 8 | August 27, 2026 |
| [Virginia](https://specstream.ai/data/fda-clearances/state/virginia) | 6 | September 3, 2026 |
| [Missouri](https://specstream.ai/data/fda-clearances/state/missouri) | 6 | August 27, 2026 |
| [Utah](https://specstream.ai/data/fda-clearances/state/utah) | 5 | September 28, 2026 |
| [Georgia](https://specstream.ai/data/fda-clearances/state/georgia) | 4 | June 1, 2026 |
| [Wisconsin](https://specstream.ai/data/fda-clearances/state/wisconsin) | 4 | May 3, 2026 |
| [Ohio](https://specstream.ai/data/fda-clearances/state/ohio) | 4 | October 8, 2025 |
| Wyoming | 2 | September 21, 2026 |
| [Washington](https://specstream.ai/data/fda-clearances/state/washington) | 2 | August 20, 2026 |
| [New Hampshire](https://specstream.ai/data/fda-clearances/state/new-hampshire) | 2 | December 22, 2025 |
| Rhode Island | 2 | June 10, 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/).