# FDA Cardiovascular device clearances: 3,161 since Nov 2024

Updated October 30, 2026.

FDA made 3,161 device decisions in cardiovascular (FDA review panel) from November 12, 2024 to October 30, 2026: 763 510(k) clearances and De Novo grants and 2,398 PMA approvals and supplements, for 513 applicants. The newest, P200026/S020 on October 30, 2026, is Abre Venous Self-expanding Stent System from Medtronic Vascular, Inc..

## The full list

FDA cardiovascular device clearances and approvals: 3,161 rows for $111.61, 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 126 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, date received, device type 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/panel/cardiovascular

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: 3,161
- 510(k) and De Novo: 763
- PMA: 2,398
- Latest decision: October 30, 2026

## Newest decisions

The newest 100 of 3,161, 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 | P200026/S020 | Abre Venous Self-expanding Stent System | Medtronic Vascular, Inc. | Minnesota | Approved | PMA special supplement | QAN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200026S020) |
| 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 | 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 30, 2026 | P150006/S009 | CELT ACD VASCULAR CLOSURE DEVICE | Vasorum, Ltd. |  | Approved | PMA special supplement | MGB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150006S009) |
| October 30, 2026 | K263587 | Arctic Sun™ Neonatal ArcticGel™ Pad | Medivance, Inc. | Colorado | Substantially Equivalent | 510(k) special | DWJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263587) |
| October 30, 2026 | K263076 | AngioVac F1885 | AngioDynamics, Inc. | New York | Substantially Equivalent | 510(k) traditional | DWF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263076) |
| October 30, 2026 | K262816 | EXG PulseLinQ Cables (EXGPL) | Cb Innovations, LLC | California | Substantially Equivalent | 510(k) traditional | DSA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262816) |
| October 30, 2026 | K261886 | VIVO (9002) | Catheter Precision, Inc. | South Carolina | Substantially Equivalent | 510(k) special | DQK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261886) |
| 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 | 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 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 | 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 29, 2026 | K263598 | VasQ | Laminate Medical Technologies | Israel | Substantially Equivalent | 510(k) special | QVQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263598) |
| October 29, 2026 | K263596 | DLP™ Coronary Ostial Cannulae | Medtronic, Inc. | Minnesota | Substantially Equivalent | 510(k) special | DWF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263596) |
| October 29, 2026 | K262839 | Cleerly ISCHEMIA | Cleerly, Inc. | Colorado | Substantially Equivalent | 510(k) special | QXZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262839) |
| 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 | 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 | 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 | 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 | K261628 | LymphaTech Mobile 3D Measuring Tool | Lymphatech, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | OBH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261628) |
| October 28, 2026 | K260670 | YUWELL® Electronic Blood Pressure Monitor | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | DXN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260670) |
| October 27, 2026 | P260019 | Amplatzer Paraclose PVL Occluder | Abbott Medical | Minnesota | Approved | PMA original approval | SJT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P260019) |
| October 27, 2026 | P240044/S007 | Globe® Catheter and Globe® Pulsed Field System | Kardium, Inc. |  | Approved | PMA real-time process supplement | QZI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240044S007) |
| 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 27, 2026 | K261714 | FlowXL® System: FlowXL Flowmeter and compatible Flowprobes and Flowsensors | Transonic Systems, Inc. | New York | Substantially Equivalent | 510(k) traditional | DPW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261714) |
| October 27, 2026 | K260586 | Nimbl™ Pneumatic Compression System | Tactile Medical | Minnesota | Substantially Equivalent | 510(k) traditional | JOW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260586) |
| October 27, 2026 | K254226 | PulseAPI SmartWatch | PulseAI, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | DQK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254226) |
| 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 | 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 | K262864 | FLOWRUNNER Aspiration System | Expanse Medical, Inc. | California | Substantially Equivalent | 510(k) traditional | QEZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262864) |
| 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 | 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 | P250003/S011 | Embrace® Hydrogel Embolic System | Instylla, Inc. | Massachusetts | Approved | PMA special supplement | QVG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250003S011) |
| October 23, 2026 | P250003/S008 | Embrace(TM) Hydrogel Embolic System | Instylla, Inc. | Massachusetts | Approved | PMA panel track supplement | QVG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250003S008) |
| 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 | 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 | 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 | 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 23, 2026 | K263380 | STAR Apollo™ Mapping System | Rhythm AI, Ltd. | United Kingdom | Substantially Equivalent | 510(k) special | DQK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263380) |
| October 23, 2026 | K260640 | Kinetic Software Library | Monebo Technologies, Inc. | Texas | Substantially Equivalent | 510(k) traditional | DPS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260640) |
| 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 | P220003/S032 | PASCAL Precision Transcatheter Valve Repair System | Edwards Lifesciences, LLC | California | Approved | PMA real-time process supplement | NKM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220003S032) |
| 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 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 22, 2026 | K260686 | Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring Catheter | Zylox Medtech Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | PNO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260686) |
| 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 | P900056/S226 | ROTAPRO™ Rotational Atherectomy Systems | Boston Scientific Corp | Minnesota | Approved | PMA real-time process supplement | MCX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P900056S226) |
| October 21, 2026 | P250003/S010 | Embrace(TM) Hydrogel Embolic System | Instylla, Inc. | Massachusetts | Approved | PMA special supplement | QVG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250003S010) |
| October 21, 2026 | P230013/S033 | EVOQUE Tricuspid Valve Replacement System | Edwards Lifesciences, LLC | California | Approved | PMA real-time process supplement | NPW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230013S033) |
| 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 21, 2026 | K262021 | Toro 71 Aspiration Catheter; Toro Aspiration Tubing | Toro Neurovascular, Inc. | California | Substantially Equivalent | 510(k) traditional | NRY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262021) |
| October 21, 2026 | K252736 | Hemotag Analysis Software (HAS) | Aventusoft, LLC | Florida | Substantially Equivalent | 510(k) traditional | DQD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252736) |
| 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 20, 2026 | P220003/S029 | PASCAL Precision Transcatheter Valve Repair System | Edwards Lifesciences, LLC | California | Approved | PMA panel track supplement | NPS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220003S029) |
| 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 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 | K262917 | Reprocessed BRK Transseptal Needle | Innovative Health, LLC | Arizona | Substantially Equivalent | 510(k) traditional | NMK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262917) |
| 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 | P250015 | PerQseal® Elite Vascular Closure Device | Vivasure Medical , Ltd. |  | Approved | PMA original approval | MGB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250015) |
| October 16, 2026 | P230040/S031 | Cordelia™ Pulmonary Artery Pressure Sensor System (CorPASS) | Endotronix, Inc. | Illinois | Approved | PMA real-time process supplement | MOM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230040S031) |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 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 16, 2026 | K263266 | Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set | Route 92 Medical, Inc. | California | Substantially Equivalent | 510(k) special | NRY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263266) |
| October 16, 2026 | K260801 | Sensinel Cardiopulmonary Management (CPM) System | Analog Devices | Massachusetts | Substantially Equivalent | 510(k) traditional | MWI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260801) |
| October 16, 2026 | K260168 | Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) | Skycade Med Corporation | Texas | Substantially Equivalent | 510(k) traditional | DQX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260168) |
| 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 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 | P020036/S061 | S.M.A.R.T. ® CONTROL® Nitinol Stent System | Cordis US Corporation | Florida | 30-day notice accepted | PMA 30-day notice | NIO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P020036S061) |
| October 15, 2026 | N16837/S040 | Artegraft Collagen Vascular Graft | LeMaitre Vascular, Inc. | Massachusetts | 30-day notice accepted | PMA 30-day notice | LXA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=N16837S040) |
| October 15, 2026 | K262904 | INDIGO® Aspiration System | Penumbra, Inc. | California | Substantially Equivalent | 510(k) traditional | QEW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262904) |
| October 15, 2026 | K262674 | Giranel Guiding Sheath Set | Kossel Medtech (Suzhou) Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | DYB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262674) |
| October 15, 2026 | K262447 | The Circadia CX00 System (CX00) | Circadia Health, Inc. | California | Substantially Equivalent | 510(k) traditional | DRT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262447) |
| October 14, 2026 | P230040/S034 | 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=P230040S034) |
| October 14, 2026 | P180036/S046 | OPTIMIZER Smart and Smart Mini System | Impulse Dynamics (Usa), Inc. | New Jersey | 30-day notice accepted | PMA 30-day notice | QFV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180036S046) |
| 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) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Medtronic, Inc. | 425 | October 29, 2026 |
| Abbott Medical | 371 | October 29, 2026 |
| Medtronic Cardiac Rhythm Disease Management | 160 | October 29, 2026 |
| Biotronik, Inc. | 137 | October 28, 2026 |
| Edwards Lifesciences, LLC | 134 | October 28, 2026 |
| Boston Scientific Corp | 101 | October 21, 2026 |
| Boston Scientific | 84 | October 3, 2026 |
| W. L. Gore & Associates, Inc. | 73 | October 8, 2026 |
| Medtronic Vascular, Inc. | 63 | October 30, 2026 |
| Boston Scientific Corporation | 62 | October 2, 2026 |
| Biosense Webster, Inc. | 58 | September 15, 2026 |
| Biotronik AG | 41 | September 24, 2026 |
| Cordis US Corporation | 38 | October 15, 2026 |
| ZOLL Medical Corporation | 32 | October 16, 2026 |
| Endotronix, Inc. | 30 | October 29, 2026 |
| Medtronic Vascular | 28 | October 16, 2026 |
| Physio-Control, Inc. | 27 | October 29, 2026 |
| Abiomed, Inc. | 26 | October 26, 2026 |
| Abbott Vascular, Inc. | 22 | October 26, 2026 |
| Bolton Medical, Inc. | 21 | October 28, 2026 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [PMA 30-day notice](https://specstream.ai/data/fda-clearances/decision/pma-30-day-notice) | 1,570 | October 30, 2026 |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 564 | October 30, 2026 |
| [PMA 180-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-180-day-supplement) | 333 | October 29, 2026 |
| [PMA real-time process supplement](https://specstream.ai/data/fda-clearances/decision/pma-real-time-process-supplement) | 280 | October 27, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 188 | October 30, 2026 |
| [PMA 135-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-135-day-supplement) | 104 | October 30, 2026 |
| [PMA special supplement](https://specstream.ai/data/fda-clearances/decision/pma-special-supplement) | 69 | October 30, 2026 |
| [PMA original approval](https://specstream.ai/data/fda-clearances/decision/pma-original-approval) | 24 | October 27, 2026 |
| [PMA panel track supplement](https://specstream.ai/data/fda-clearances/decision/pma-panel-track-supplement) | 18 | October 23, 2026 |
| [510(k) abbreviated](https://specstream.ai/data/fda-clearances/decision/510k-abbreviated) | 6 | September 4, 2026 |
| [De Novo](https://specstream.ai/data/fda-clearances/decision/de-novo) | 5 | September 29, 2026 |

## By state or country

| State or country | Decisions | Latest |
| --- | --- | --- |
| [Minnesota](https://specstream.ai/data/fda-clearances/state/minnesota) | 1,045 | October 30, 2026 |
| [California](https://specstream.ai/data/fda-clearances/state/california) | 868 | October 30, 2026 |
| [Oregon](https://specstream.ai/data/fda-clearances/state/oregon) | 145 | October 28, 2026 |
| [China](https://specstream.ai/data/fda-clearances/country/china) | 115 | October 28, 2026 |
| [Arizona](https://specstream.ai/data/fda-clearances/state/arizona) | 112 | October 23, 2026 |
| [Massachusetts](https://specstream.ai/data/fda-clearances/state/massachusetts) | 104 | October 26, 2026 |
| [Florida](https://specstream.ai/data/fda-clearances/state/florida) | 70 | October 28, 2026 |
| [Illinois](https://specstream.ai/data/fda-clearances/state/illinois) | 48 | October 29, 2026 |
| [Washington](https://specstream.ai/data/fda-clearances/state/washington) | 47 | October 29, 2026 |
| [Georgia](https://specstream.ai/data/fda-clearances/state/georgia) | 35 | October 28, 2026 |
| [Utah](https://specstream.ai/data/fda-clearances/state/utah) | 31 | September 16, 2026 |
| [Texas](https://specstream.ai/data/fda-clearances/state/texas) | 26 | October 30, 2026 |
| [Ireland](https://specstream.ai/data/fda-clearances/country/ireland) | 26 | August 14, 2026 |
| [Pennsylvania](https://specstream.ai/data/fda-clearances/state/pennsylvania) | 25 | October 6, 2026 |
| [Italy](https://specstream.ai/data/fda-clearances/country/italy) | 22 | October 1, 2026 |
| [Colorado](https://specstream.ai/data/fda-clearances/state/colorado) | 20 | October 30, 2026 |
| [Germany](https://specstream.ai/data/fda-clearances/country/germany) | 20 | July 8, 2026 |
| [New York](https://specstream.ai/data/fda-clearances/state/new-york) | 18 | October 30, 2026 |
| [Israel](https://specstream.ai/data/fda-clearances/country/israel) | 17 | October 29, 2026 |
| [Japan](https://specstream.ai/data/fda-clearances/country/japan) | 17 | September 3, 2026 |
| [Ohio](https://specstream.ai/data/fda-clearances/state/ohio) | 16 | October 1, 2026 |
| [North Carolina](https://specstream.ai/data/fda-clearances/state/north-carolina) | 15 | July 29, 2026 |
| [New Jersey](https://specstream.ai/data/fda-clearances/state/new-jersey) | 14 | October 14, 2026 |
| [Canada](https://specstream.ai/data/fda-clearances/country/canada) | 14 | July 23, 2026 |
| [United Kingdom](https://specstream.ai/data/fda-clearances/country/united-kingdom) | 11 | October 27, 2026 |

## 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/).