# FDA device clearances in Minnesota: 1,513 since Nov 2024

Updated October 30, 2026.

FDA made 1,513 device decisions for applicants in Minnesota from November 12, 2024 to October 30, 2026: 153 510(k) clearances and De Novo grants and 1,360 PMA approvals and supplements, for 92 applicants. The newest, P960009/S548 on October 30, 2026, is Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ from Medtronic, Inc..

## The full list

FDA device clearances for applicants in Minnesota: 1,513 rows for $75.65, 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 50 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 5 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/state/minnesota

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: 1,513
- 510(k) and De Novo: 153
- PMA: 1,360
- Latest decision: October 30, 2026

## Newest decisions

The newest 100 of 1,513, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

| Decision date | Number | Device | Applicant | Location | Decision | Type | Product code | Source |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| October 30, 2026 | P960009/S548 | Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ | Medtronic, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | MHY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960009S548) |
| October 30, 2026 | P860004/S465 | SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters | Medtronic, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | LKK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P860004S465) |
| October 30, 2026 | P840001/S636 | Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces-Quad™... | Medtronic Neuromodulation | Minnesota | 30-day notice accepted | PMA 30-day notice | LGW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P840001S636) |
| October 30, 2026 | 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 29, 2026 | P980035/S849 | Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra XT SR MRI IPG; Azure S DR MRI IPG; Azure S... | Medtronic, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | NVZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980035S849) |
| October 29, 2026 | P980016/S967 | Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD | Medtronic Cardiac Rhythm Disease Management | Minnesota | 30-day notice accepted | PMA 30-day notice | LWS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980016S967) |
| October 29, 2026 | P970004/S460 | InterStim™ Therapy System, Verify™ Evaluation System (SNS Urinary Neurostimulator 97800), (SNS Urinary... | Medtronic Neuromodulation | Minnesota | 30-day notice accepted | PMA 30-day notice | EZW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970004S460) |
| October 29, 2026 | P960009/S547 | Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (DBS Neurostimulator Implantable... | Medtronic, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | MHY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960009S547) |
| October 29, 2026 | P860004/S464 | SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters TDD (Drug Delivery Infusion Pump 8667), TDD (Drug... | Medtronic, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | LKK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P860004S464) |
| October 29, 2026 | P840001/S635 | Master Restore™, Itrel™, Synergy Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and Pisces™... | Medtronic Neuromodulation | Minnesota | 30-day notice accepted | PMA 30-day notice | LGW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P840001S635) |
| October 29, 2026 | 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 | P080025/S354 | InterStim™ Therapy System, Verify™ Evaluation System (SNS Bowel Neurostimulator 97800), (SNS Bowel... | Medtronic Neuromodulation | Minnesota | 30-day notice accepted | PMA 30-day notice | QON | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P080025S354) |
| October 29, 2026 | P010031/S934 | Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D | Medtronic Cardiac Rhythm Disease Management | Minnesota | 30-day notice accepted | PMA 30-day notice | NIK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010031S934) |
| October 29, 2026 | P010015/S592 | Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara... | Medtronic, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | LWP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010015S592) |
| October 29, 2026 | K263648 | Vitrea Advanced Visualization, Version 7.16 | Canon Medical Informatics, Inc. | Minnesota | Substantially Equivalent | 510(k) special | LLZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263648) |
| 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 28, 2026 | K263583 | Tornier Humeral Reconstruction System (HRS) Tuberosity Body | Tornier, Inc. | Minnesota | Substantially Equivalent | 510(k) special | KWS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263583) |
| October 28, 2026 | K263512 | Luja female | Coloplast Corp. | Minnesota | Substantially Equivalent | 510(k) special | EZD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263512) |
| 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 | 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 | 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 26, 2026 | P130008/S144 | INSPIRE II UPPER AIRWAY STIMULATOR | Inspire Medical Systems | Minnesota | Approved | PMA real-time process supplement | MNQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130008S144) |
| October 26, 2026 | K260285 | Triad Hydrophilic Wound Dresssing (1964, 2.5 oz); Triad Hydrophilic Wound Dressing (1967, 6 oz) | Coloplast Corp. | Minnesota | Substantially Equivalent | 510(k) traditional | FRO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260285) |
| 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 | 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 | 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 | K261792 | DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent | Medtronic | Minnesota | Substantially Equivalent | 510(k) traditional |  | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261792) |
| October 22, 2026 | P130008/S147 | Model 3150 IPG | Inspire Medical Systems | Minnesota | 30-day notice accepted | PMA 30-day notice | MNQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130008S147) |
| October 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 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 | K262597 | Access BNP II | Beckman Coulter, Inc. | Minnesota | Substantially Equivalent | 510(k) traditional | NBC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262597) |
| October 19, 2026 | K261109 | Access MeMed BV | Beckman Coulter, Inc. | Minnesota | Substantially Equivalent | 510(k) traditional | QPS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261109) |
| October 16, 2026 | P860004/S462 | SynchroMed™ Infusion System, Ascenda ™ Intrathecal Catheters | Medtronic, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | LKK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P860004S462) |
| October 16, 2026 | 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 | 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 | 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 | P030045/S011 | Visi-Pro™ balloon-Expandable peripheral stent system | Medtronic Vascular, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | NIO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030045S011) |
| October 16, 2026 | P030036/S162 | MEDTRONIC SELECTSECURE LEAD MODEL 3830 | Medtronic Cardiac Rhythm Disease Management | Minnesota | 30-day notice accepted | PMA 30-day notice | NVN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030036S162) |
| October 15, 2026 | 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 | P090018/S044 | Esteem® | Envoy Medical Corporation | Minnesota | 30-day notice accepted | PMA 30-day notice | OAF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P090018S044) |
| October 13, 2026 | P130008/S146 | Model 3150 IPG | Inspire Medical Systems | Minnesota | 30-day notice accepted | PMA 30-day notice | MNQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130008S146) |
| October 9, 2026 | P970004/S459 | InterStim™ Therapy System, Verify™ Evaluation System | Medtronic Neuromodulation | Minnesota | 30-day notice accepted | PMA 30-day notice | EZW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970004S459) |
| October 9, 2026 | P240013/S032 | Affera Sphere-9 Mapping and Ablation Catheter | Medtronic, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | QZI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240013S032) |
| October 9, 2026 | P080025/S353 | InterStim™ Therapy System, Verify™ Evaluation System | Medtronic Neuromodulation | Minnesota | 30-day notice accepted | PMA 30-day notice | QON | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P080025S353) |
| October 8, 2026 | P250022/S012 | VOLT™ PFA CATHETER, SENSOR ENABLED™ | Abbott Medical | Minnesota | 30-day notice accepted | PMA 30-day notice | QZI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250022S012) |
| October 8, 2026 | P250022/S009 | Volt™ PFA Catheter, Sensor Enabled™ | Abbott Medical | Minnesota | 30-day notice accepted | PMA 30-day notice | QZI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250022S009) |
| October 6, 2026 | P970004/S457 | InterStim™ Therapy System, Verify™ Evaluation System | Medtronic Neuromodulation | Minnesota | Approved | PMA real-time process supplement | EZW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970004S457) |
| October 6, 2026 | P960009/S542 | Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ | Medtronic, Inc. | Minnesota | Approved | PMA real-time process supplement | MHY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960009S542) |
| October 6, 2026 | P840001/S632 | Master Vanta™ with Restore™, Itrel™, Synergy™, Intellis™, AdaptiveStim™ Vanta™ and Inceptiv TM Spinal Cord... | Medtronic Neuromodulation | Minnesota | Approved | PMA real-time process supplement | LGW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P840001S632) |
| October 6, 2026 | P240013/S028 | Sphere-9 Catheter™ and Affera™ Ablation System | Medtronic, Inc. | Minnesota | Approved | PMA real-time process supplement | QZI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240013S028) |
| October 6, 2026 | P080025/S351 | lnterStim™ Therapy System, Verify™ Evaluation System | Medtronic Neuromodulation | Minnesota | Approved | PMA real-time process supplement | QON | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P080025S351) |
| October 6, 2026 | K261141 | OpenFlo Urinary Catheter | Urolution Medical, Inc. | Minnesota | Substantially Equivalent | 510(k) traditional | EZL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261141) |
| October 5, 2026 | P980035/S847 | Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG, Azure XT... | 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=P980035S847) |
| October 5, 2026 | P980016/S966 | Cobalt MRI ICD (DDPB3Dl, DDPB3D4, DVPB3Dl, DVPB3D4); Cobalt XT MRI ICD (DDPA2Dl, DDPA2D4, DVPA2Dl, DVPA2D4)... | 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=P980016S966) |
| October 5, 2026 | P010031/S933 | Cobalt MRI CRT-D (DTPB2Dl, DTPB2D4, DTPB2Ql, DTPB2QQ); Cobalt XT MRI CRT-D (DTPA2Dl, DTPA2D4, DTPA2Ql... | 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=P010031S933) |
| October 5, 2026 | P010015/S590 | 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=P010015S590) |
| October 3, 2026 | P150012/S191 | ESSENTIO MRI (Model L131); PROPONENT MRI (Model L231); ACCOLADE MRI (Model L331); ESSENTIO™ MRI (Models L110... | Boston Scientific | 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=P150012S191) |
| October 3, 2026 | P030005/S257 | VALITUDE™ (Model U125); VALITUDE X4 (Model U128); VISIONIST™ (Models U225, U226); VISIONIST X4 (Model U228) | Guidant Corp. | Minnesota | 30-day notice accepted | PMA 30-day notice | NKE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030005S257) |
| October 3, 2026 | N970003/S311 | ALTRUA™ 2 (Model S722); ESSENTIO™ (Model L121); PROPONENT™ (Model L221); ACCOLADE™ (Model L321); ALTRUA™ 2... | Boston Scientific Corp | 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=N970003S311) |
| October 2, 2026 | P240013/S031 | Sphere-9 Catheter and Affera Ablation System | Medtronic, Inc. | Minnesota | Approved | PMA real-time process supplement | QZI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240013S031) |
| October 2, 2026 | P110042/S216 | EMBLEM™ Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) high voltage (HV) Capacitor | Boston Scientific Corporation | 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=P110042S216) |
| September 25, 2026 | P980016/S965 | 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=P980016S965) |
| 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 | P010031/S932 | 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=P010031S932) |
| September 24, 2026 | P960009/S546 | MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM | Medtronic, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | MHY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960009S546) |
| September 24, 2026 | P840001/S634 | Vanta™with AdaptiveStim™ Technology - Model 977006 | Medtronic Neuromodulation | Minnesota | 30-day notice accepted | PMA 30-day notice | LGW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P840001S634) |
| September 24, 2026 | P180047/S046 | LIAISON® QuantiFERON®-TB Gold Plus II. | DiaSorin, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | NCD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180047S046) |
| September 23, 2026 | P100047/S241 | HeartWare® HVAD System | Medtronic | Minnesota | Approved | PMA special supplement | DSQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100047S241) |
| 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 21, 2026 | K262109 | Access NT-proBNP | Beckman Coulter, Inc. | Minnesota | Substantially Equivalent | 510(k) traditional | NBC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262109) |
| September 18, 2026 | P040021/S063 | Epic™ Plus, Epic™ Plus Supra, Epic™ Max, Epic™ Elite, Epic™ Supra G3 Tissue Heart Valves | Abbott Medical | Minnesota | 30-day notice accepted | PMA 30-day notice | LWR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P040021S063) |
| September 17, 2026 | P910073/S193 | ENDOTAK LEAD SYSTEM | Boston Scientific | Minnesota | Approved | PMA special supplement | LWS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P910073S193) |
| September 17, 2026 | K262913 | Protégé™ EverFlex™ Self-expanding Peripheral Stent System | Medtronic, Inc. | Minnesota | Substantially Equivalent | 510(k) special | FGE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262913) |
| September 17, 2026 | K261729 | EnSite™ X EP System | Abbott Medical | Minnesota | Substantially Equivalent | 510(k) traditional | DQK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261729) |
| September 16, 2026 | K261467 | GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) | Gt Metabolic Solutions, Inc. | Minnesota | Substantially Equivalent | 510(k) traditional | SAH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261467) |
| September 14, 2026 | P970004/S458 | InterStim™ Therapy System Verify™ Evaluation System | Medtronic Neuromodulation | Minnesota | 30-day notice accepted | PMA 30-day notice | EZW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970004S458) |
| September 14, 2026 | P240011/S016 | Altaviva™ | Medtronic Neuromodulation | Minnesota | 30-day notice accepted | PMA 30-day notice | QPT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240011S016) |
| September 14, 2026 | P080025/S352 | InterStim™ Therapy System, Verify™ Evaluation System | Medtronic Neuromodulation | Minnesota | 30-day notice accepted | PMA 30-day notice | QON | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P080025S352) |
| September 11, 2026 | K254041 | SkinSmart Antimicrobial HydroGel | Magic Science Supply, LLC | Minnesota | Substantially Equivalent | 510(k) traditional | FRO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254041) |
| September 8, 2026 | P150033/S230 | Micra Functional Testing on pNGHT and NGHT | Medtronic, Inc. | Minnesota | 30-day notice accepted | PMA 30-day notice | PNJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150033S230) |
| September 4, 2026 | P220013/S028 | TactiFlex™ Duo Ablation Catheter, Sensor Enabled™ (A-TFDM-D, A-TFDM-F, A-TFDM-J, A-TFDM-DD, A-TFDM-DF... | Abbott Medical | Minnesota | Approved | PMA panel track supplement | OAE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220013S028) |
| September 4, 2026 | K262277 | 70 NeuGlide Catheter | Piraeus Medical, Inc. | Minnesota | Substantially Equivalent | 510(k) special | QJP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262277) |
| September 3, 2026 | K262315 | NeuroBlate System | Monteris Medical | Minnesota | Substantially Equivalent | 510(k) traditional | ONO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262315) |
| September 3, 2026 | K253673 | M•care System (MW-20) | Marani Health, Inc. | Minnesota | Substantially Equivalent | 510(k) traditional | LQK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253673) |
| August 31, 2026 | P240042/S004 | Tendyne Transcatheter Mitral Valve System | Abbott Medical | Minnesota | 30-day notice accepted | PMA 30-day notice | NPU | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240042S004) |
| August 28, 2026 | P230035/S010 | AGENT Paclitaxel-Coated Balloon Catheter | Boston Scientific Corporation | Minnesota | 30-day notice accepted | PMA 30-day notice | OOB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230035S010) |
| August 28, 2026 | P200049/S021 | Amplatzer™ Amulet™ Left Atrial Appendage Occluder | Abbott Medical | Minnesota | Approved | PMA special supplement | NGV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200049S021) |
| August 28, 2026 | P130013/S090 | WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System; WATCHMAN FLX Pro Left Atrial... | Boston Scientific Corp | Minnesota | 30-day notice accepted | PMA 30-day notice | NGV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130013S090) |
| 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 28, 2026 | K262735 | LINQ II Insertable Cardiac Monitor (ICM) (LNQ22) | Medtronic, Inc. | Minnesota | Substantially Equivalent | 510(k) special | MXD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262735) |
| August 27, 2026 | P180047/S045 | LIAISON QuantiFERON-TB Gold III; LIAISON Control QuantiFERON-TB Gold III; LIAISON QuantiFERON-TB Gold Plus... | DiaSorin, Inc. | Minnesota | Approved | PMA real-time process supplement | NCD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P180047S045) |
| 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 | K260751 | 35 Helix Guidewire | Piraeus Medical, Inc. | Minnesota | Substantially Equivalent | 510(k) traditional | MOF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260751) |
| August 26, 2026 | P230021/S004 | Duo Venous Stent System | Philips Image Guided Therapy Corporation | 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=P230021S004) |
| August 25, 2026 | P960040/S515 | Tachy Pulse Generators | Boston Scientific | Minnesota | Approved | PMA real-time process supplement | LWS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P960040S515) |
| August 25, 2026 | P010012/S612 | Tachy Pulse Generators | Boston Scientific Corp | Minnesota | Approved | PMA real-time process supplement | NIK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010012S612) |
| August 24, 2026 | K260604 | BiWaze Clear System | Abmrc, LLC | Minnesota | Substantially Equivalent | 510(k) traditional | NHJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260604) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Medtronic, Inc. | 444 | October 30, 2026 |
| Medtronic Neuromodulation | 177 | October 30, 2026 |
| Medtronic Cardiac Rhythm Disease Management | 160 | October 29, 2026 |
| Abbott Medical | 142 | October 29, 2026 |
| Boston Scientific Corp | 95 | October 21, 2026 |
| Boston Scientific | 85 | October 3, 2026 |
| DiaSorin, Inc. | 64 | September 24, 2026 |
| Boston Scientific Corporation | 58 | October 2, 2026 |
| Medtronic Vascular, Inc. | 47 | October 30, 2026 |
| Inspire Medical Systems | 30 | October 26, 2026 |
| Medtronic | 19 | October 23, 2026 |
| Coloplast Corp. | 15 | October 28, 2026 |
| St Jude Medical | 15 | August 7, 2026 |
| Guidant Corp. | 14 | October 3, 2026 |
| Beckman Coulter, Inc. | 11 | October 20, 2026 |
| Medtronic Cryocath, LP | 10 | September 25, 2026 |
| Cardiovascular Systems, Inc. | 8 | March 10, 2026 |
| Canon Medical Informatics, Inc. | 4 | October 29, 2026 |
| Tornier, Inc. | 4 | October 28, 2026 |
| Philips Image Guided Therapy Corporation | 4 | August 26, 2026 |

## By panel

| Panel | Decisions | Latest |
| --- | --- | --- |
| [Cardiovascular](https://specstream.ai/data/fda-clearances/panel/cardiovascular) | 1,045 | October 30, 2026 |
| [Gastroenterology, Urology](https://specstream.ai/data/fda-clearances/panel/gastroenterology-urology) | 156 | October 29, 2026 |
| [Neurology](https://specstream.ai/data/fda-clearances/panel/neurology) | 123 | October 30, 2026 |
| [Microbiology](https://specstream.ai/data/fda-clearances/panel/microbiology) | 71 | October 19, 2026 |
| [General Hospital](https://specstream.ai/data/fda-clearances/panel/general-hospital) | 37 | October 30, 2026 |
| [Anesthesiology](https://specstream.ai/data/fda-clearances/panel/anesthesiology) | 35 | October 26, 2026 |
| [Orthopedic](https://specstream.ai/data/fda-clearances/panel/orthopedic) | 12 | October 28, 2026 |
| [Radiology](https://specstream.ai/data/fda-clearances/panel/radiology) | 9 | October 29, 2026 |
| [General, Plastic Surgery](https://specstream.ai/data/fda-clearances/panel/general-plastic-surgery) | 8 | September 16, 2026 |
| [Ear, Nose, Throat](https://specstream.ai/data/fda-clearances/panel/ear-nose-throat) | 5 | October 15, 2026 |
| [Clinical Chemistry](https://specstream.ai/data/fda-clearances/panel/clinical-chemistry) | 4 | October 20, 2026 |
| Unknown | 3 | October 26, 2026 |
| [Immunology](https://specstream.ai/data/fda-clearances/panel/immunology) | 2 | December 23, 2025 |
| [Obstetrics/Gynecology](https://specstream.ai/data/fda-clearances/panel/obstetrics-gynecology) | 1 | September 3, 2026 |
| [Clinical Toxicology](https://specstream.ai/data/fda-clearances/panel/clinical-toxicology) | 1 | November 26, 2025 |
| [Physical Medicine](https://specstream.ai/data/fda-clearances/panel/physical-medicine) | 1 | December 18, 2024 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [PMA 30-day notice](https://specstream.ai/data/fda-clearances/decision/pma-30-day-notice) | 973 | October 30, 2026 |
| [PMA real-time process supplement](https://specstream.ai/data/fda-clearances/decision/pma-real-time-process-supplement) | 155 | October 26, 2026 |
| [PMA 180-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-180-day-supplement) | 130 | October 29, 2026 |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 105 | October 27, 2026 |
| [PMA 135-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-135-day-supplement) | 70 | September 22, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 47 | October 29, 2026 |
| [PMA special supplement](https://specstream.ai/data/fda-clearances/decision/pma-special-supplement) | 18 | October 30, 2026 |
| [PMA original approval](https://specstream.ai/data/fda-clearances/decision/pma-original-approval) | 8 | October 27, 2026 |
| [PMA panel track supplement](https://specstream.ai/data/fda-clearances/decision/pma-panel-track-supplement) | 6 | September 4, 2026 |
| [De Novo](https://specstream.ai/data/fda-clearances/decision/de-novo) | 1 | December 23, 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/).