# FDA device clearances in Oregon: 174 since Nov 2024

Updated October 29, 2026.

FDA made 174 device decisions for applicants in Oregon from November 15, 2024 to October 29, 2026: 32 510(k) clearances and De Novo grants and 142 PMA approvals and supplements, for 16 applicants. The newest, K262570 on October 29, 2026, is TZ Medical Birthing Balloon Kit from TZ Medical.

## The full list

FDA device clearances for applicants in Oregon: 174 rows for $8.70, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. Columns: Number, Pathway, Device name, Applicant, Applicant address, Contact, Decision, Decision date, Decision type, Date received, Product code, Device type, Device class, Panel, Applicant state, Applicant country, Supplement reason, Read on, Source. The new rows each week by email, about 6 rows a month: $19 a month. Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (contact, pathway, device name, applicant address, 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/oregon

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: 174
- 510(k) and De Novo: 32
- PMA: 142
- Latest decision: October 29, 2026

## Newest decisions

The newest 100 of 174, 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 29, 2026 | K262570 | TZ Medical Birthing Balloon Kit | TZ Medical | Oregon | Substantially Equivalent | 510(k) traditional | PFJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262570) |
| 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 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 | 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 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 | 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 13, 2026 | P980023/S152 | Ilivia Neo 7 VR-T DX DF-1 ProMRI, Ilivia Neo 7 VR-T DF-1 ProMRI, Intica Neo 7 VR-T DX DF-1 ProMRI, Intica Neo... | 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=P980023S152) |
| October 13, 2026 | P950037/S298 | Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos 4... | 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=P950037S298) |
| October 13, 2026 | P070008/S183 | Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T | 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=P070008S183) |
| October 13, 2026 | P050023/S215 | Ilivia 7 VR-T DX DF-1 ProMRI Ilivia 7 VR-T DF-1 ProMRI Ilivia 7 VR-T DF4 ProMRI Intica 7 VR-T DX DF-1 ProMRI... | 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=P050023S215) |
| October 13, 2026 | P000009/S134 | Intica Neo 7 DR-T DF-1 ProMRI, Intica Neo 5 DR-T DF-1 ProMRI | 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=P000009S134) |
| October 9, 2026 | P980023/S149 | Acticor Sky VR-T 481989; Rivacor Sky VR-T 481984; Rivacor Rise VR-T 482020; Rivacor Aura VR-T 482015; Acticor... | Biotronik, Inc. | Oregon | Approved | PMA real-time process supplement | LWS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980023S149) |
| October 9, 2026 | P950037/S296 | 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 real-time process supplement | DXY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P950037S296) |
| October 9, 2026 | P070008/S181 | 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... | Biotronik, Inc. | Oregon | Approved | PMA real-time process supplement | NKE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P070008S181) |
| October 9, 2026 | P050023/S213 | Acticor Sky HF-T 481986; Rivacor Sky HF-T 481991; Rivacor Rise HF-T 482017; Rivacor Aura HF-T 482013; Acticor... | Biotronik, Inc. | Oregon | Approved | PMA real-time process supplement | MRM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P050023S213) |
| October 9, 2026 | P000009/S132 | Acticor Sky DR-T 481987; Rivacor Sky DR-T 481982; Rivacor Rise DR-T 482018; Rivacor Aura DR-T 482014 | Biotronik, Inc. | Oregon | Approved | PMA real-time process supplement | MRM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000009S132) |
| October 5, 2026 | P070008/S182 | Edora 8 HF-T QP Edora 8 HF-T Evity 8 HF-T QP Evity 8 HF-T Enitra 8 HF-T QP Enitra 8 HF-T Enticos 8 HF-T QP... | 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=P070008S182) |
| September 29, 2026 | K263073 | Fast Absorbing PGLA | Riverpoint Medical, LLC | Oregon | Substantially Equivalent | 510(k) special | GAM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263073) |
| September 25, 2026 | P980023/S151 | Acticor Sky VR-T, Rivacor Sky VR-T, Rivacor Rise VR-T, Rivacor Aura VR-T, Acticor Sky VR-T DX, Rivacor Sky... | 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=P980023S151) |
| 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 | 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/S214 | Acticor Sky HF-T, Rivacor Sky HF-T, Rivacor Rise HF-T, Rivacor Aura HF-T, Acticor Sky HF-T QP, Rivacor Sky... | 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=P050023S214) |
| 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/S133 | Acticor Sky DR-T, Rivacor Sky DR-T, Rivacor Rise DR-T, Rivacor Aura DR-T, Acticor 7 DR-T, Rivacor 7 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=P000009S133) |
| 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 17, 2026 | P980023/S146 | Acticor Sky VR-T, Rivacor Sky VR-T, Rivacor Rise VR-T, Rivacor Aura VR-T, Acticor Sky VR-T DX, Rivacor Sky... | Biotronik, Inc. | Oregon | Approved | PMA real-time process supplement | LWS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980023S146) |
| September 17, 2026 | P950037/S291 | PSW 2601.U, NEO 2601.U, Amvia Sky HF-T QP, Amvia Sky HF-T, Amvia Edge HF-T QP, Amvia Sky DR-T, Amvia Sky... | Biotronik, Inc. | Oregon | Approved | PMA real-time process supplement | DXY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P950037S291) |
| September 17, 2026 | P070008/S179 | PSW 2601.U, NEO 2601.U | Biotronik, Inc. | Oregon | Approved | PMA real-time process supplement | NKE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P070008S179) |
| September 17, 2026 | P050023/S211 | PSW 2601.U, NEO 2601.U, Acticor Sky HF-T, Rivacor Sky HF-T, Rivacor Rise HF-T, Rivacor Aura HF-T, Acticor Sky... | Biotronik, Inc. | Oregon | Approved | PMA real-time process supplement | MRM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P050023S211) |
| September 17, 2026 | P000009/S130 | PSW 2601.U, NEO 2601.U, Acticor Sky DR-T, Rivacor Sky DR-T, Rivacor Rise DR-T, Rivacor Aura DR-T | Biotronik, Inc. | Oregon | Approved | PMA real-time process supplement | MRM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000009S130) |
| September 10, 2026 | P980023/S150 | Pamira S 60; Pamira S 65; Pamira S 75; Pamira SD 60/16; Pamira SD 65/16; Pamira SD 65/18; Pamira SD 75/18... | 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=P980023S150) |
| August 27, 2026 | P950037/S297 | Solia CSP S | 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=P950037S297) |
| August 27, 2026 | K262677 | Iconix Knotless T | Riverpoint Medical | Oregon | Substantially Equivalent | 510(k) special | MBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262677) |
| July 1, 2026 | P980023/S148 | Plexa ProMRI S 60, Plexa ProMRI S 65, Plexa ProMRI S 75, Plexa ProMRI SD 60/16, Plexa ProMRI SD 65/16, Plexa... | 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=P980023S148) |
| July 1, 2026 | P950037/S295 | Solia T 53, Solia T 60, Solia S 45, Solia S 53, Solia S 60, Solia CSP S 53, Solia CSP S 60 | 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=P950037S295) |
| June 24, 2026 | P980023/S147 | Acticor Sky VR-T (481989); Rivacor Sky VR-T (481984); Rivacor Rise VR-T (482020); Rivacor Aura VR-T (482015)... | 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=P980023S147) |
| June 24, 2026 | P050023/S212 | Acticor 7 VR-T DX (429525); Acticor 7 VR-T DF4 ProMRI (429526); Rivacor 3 VR-T DF4 ProMRI (429574); Rivacor 5... | 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=P050023S212) |
| June 24, 2026 | P000009/S131 | Acticor Sky DR-T (481987); Rivacor Sky DR-T (481982); Rivacor Rise DR-T (482018); Rivacor Aura DR-T (482014) | 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=P000009S131) |
| June 5, 2026 | P210037/S017 | Prospera Spinal Cord Stimulation (SCS) System; Resilience Percutaneous Lead; Embrace One; TrueLock | Biotronik Nro, Inc. | Oregon | 30-day notice accepted | PMA 30-day notice | LGW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P210037S017) |
| May 28, 2026 | P950037/S293 | Siello T 53, Siello T 60, Siello JT 45, Siello JT 53, Solia T 53, Solia T 60, Solia JT 45, Solia JT 53... | 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=P950037S293) |
| May 22, 2026 | K252772 | Arc Adjustable Radial Cuff Compression Device | Tz Medical, Inc. | Oregon | Substantially Equivalent | 510(k) traditional | DXC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252772) |
| May 15, 2026 | P950037/S292 | Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes | 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=P950037S292) |
| May 14, 2026 | P210037/S012 | Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management | Biotronik Nro, Inc. | Oregon | Approved | PMA real-time process supplement | LGW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P210037S012) |
| May 7, 2026 | P980023/S145 | Acticor Sky VR-T, Rivacor Sky VR-T, Rivacor Rise VR-T, Rivacor Aura VR-T, Acticor Sky VR-T DX, Rivacor Sky... | 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=P980023S145) |
| May 7, 2026 | P950037/S290 | Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 8... | 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=P950037S290) |
| May 7, 2026 | P070008/S178 | Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Amvia Sky... | 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=P070008S178) |
| May 7, 2026 | P050023/S210 | Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR-T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, Rivacor... | Biotronik, Inc. | Oregon | 30-day notice accepted | PMA 30-day notice | MRM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P050023S210) |
| May 7, 2026 | P000009/S129 | Acticor Sky DR-T, Rivacor Sky DR-T, Rivacor Rise DR-T, Rivacor Aura 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=P000009S129) |
| May 1, 2026 | K261074 | BIOMONITOR IV (471155) | Biotronik, Inc. | Oregon | Substantially Equivalent | 510(k) special | MXD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261074) |
| April 24, 2026 | P950037/S285 | Renamic Neo | Biotronik, Inc. | Oregon | Approved | PMA real-time process supplement | DXY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P950037S285) |
| April 24, 2026 | P210037/S015 | Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management | Biotronik Nro, Inc. | Oregon | 30-day notice accepted | PMA 30-day notice | LGW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P210037S015) |
| April 24, 2026 | P070008/S175 | Renamic Neo | Biotronik, Inc. | Oregon | Approved | PMA real-time process supplement | NKE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P070008S175) |
| April 24, 2026 | P050023/S207 | Renamic Neo | Biotronik, Inc. | Oregon | Approved | PMA real-time process supplement | MRM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P050023S207) |
| April 24, 2026 | P000009/S127 | Renamic Neo | Biotronik, Inc. | Oregon | Approved | PMA real-time process supplement | MRM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000009S127) |
| April 2, 2026 | P950037/S288 | Solia CSP S Leads | Biotronik, Inc. | Oregon | Approved | PMA 180-day supplement | NVN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P950037S288) |
| March 30, 2026 | P950037/S282 | Amvia-Solvia Pulse Generators Scan Duration Extension | Biotronik, Inc. | Oregon | Approved | PMA real-time process supplement | DXY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P950037S282) |
| March 27, 2026 | P950037/S287 | Pulse Generator, Permanent Implantable Edora 8 DR-T Evity 8 DR-T Enitra 8 DR-T Enticos 8 DR-T Evity 6 DR-T... | 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=P950037S287) |
| March 25, 2026 | K252023 | MiraChlor Antimicrobial Wound Solution | Letus Corporation | Oregon | Substantially Equivalent | 510(k) traditional | FRO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252023) |
| March 11, 2026 | K253693 | Strut Suture; No-Tie Button | Riverpoint Medical, LLC | Oregon | Substantially Equivalent | 510(k) traditional | MBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253693) |
| March 5, 2026 | P980023/S144 | Acticor Sky VR-T (481989); Rivacor Sky VR-T (481984); Rivacor Rise VR-T (482020); Rivacor Aura VR-T (482015)... | 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=P980023S144) |
| March 5, 2026 | P950037/S286 | Edora 8 DR-T (407145); Evity 8 DR-T (407146); Enitra 8 DR-T (407147); Enticos 8 DR-T (407148); Evity 6 DR-T... | 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=P950037S286) |
| March 5, 2026 | P070008/S176 | Edora 8 HF-T QP (407137); Edora 8 HF-T (407138); Evity 8 HF-T QP (407139); Evity 8 HF-T (407140); Enitra 8... | 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=P070008S176) |
| March 5, 2026 | P050023/S208 | Acticor 7 VR-T (429526); Rivacor 7 VR-T (429536); Rivacor 5 VR-T (429565); Rivacor 3 VR-T (429574); Acticor 7... | 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=P050023S208) |
| February 27, 2026 | K253695 | LigaMend | Riverpoint Medical, LLC | Oregon | Substantially Equivalent | 510(k) traditional | MBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253695) |
| February 12, 2026 | P950037/S280 | Solia CSP S 53; Solia CSP S 60 | Biotronik, Inc. | Oregon | Approved | PMA 180-day supplement | NVN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P950037S280) |
| February 11, 2026 | P980023/S142 | PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM | 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=P980023S142) |
| February 11, 2026 | P950037/S283 | DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS | 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=P950037S283) |
| February 11, 2026 | P050023/S205 | TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD | 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=P050023S205) |
| February 11, 2026 | P000009/S125 | PHYLAX AV ICD SYSTEM | 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=P000009S125) |
| February 3, 2026 | P980023/S143 | PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM | 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=P980023S143) |
| February 3, 2026 | P950037/S284 | DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS | 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=P950037S284) |
| February 3, 2026 | P070008/S174 | STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD | 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=P070008S174) |
| February 3, 2026 | P050023/S206 | TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD | 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=P050023S206) |
| February 3, 2026 | P000009/S126 | PHYLAX AV ICD SYSTEM | 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=P000009S126) |
| December 19, 2025 | K250314 | Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer | Surgical Instrument Service and Savings, Inc. | Oregon | Substantially Equivalent | 510(k) traditional | PNE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250314) |
| December 18, 2025 | P980023/S136 | Acticor Sky VR-T 481989, Rivacor Sky VR-T 481984, Rivacor Rise VR-T 482020, Rivacor Aura VR-T 482015, Acticor... | Biotronik, Inc. | Oregon | Approved | PMA 180-day supplement | LWS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980023S136) |
| December 18, 2025 | P950037/S274 | Solia S 53 377177; Solia S 60 377179 | Biotronik, Inc. | Oregon | Approved | PMA 180-day supplement | DXY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P950037S274) |
| December 18, 2025 | P050023/S199 | Acticor Sky HF-T 481986, Rivacor Sky HF-T 481991, Rivacor Rise HF-T 482017, Rivacor Aura HF-T 482013, Acticor... | Biotronik, Inc. | Oregon | Approved | PMA 180-day supplement | MRM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P050023S199) |
| December 18, 2025 | P000009/S120 | Acticor Sky DR-T 481987, Rivacor Sky DR-T 481982, Rivacor Rise DR-T 482018, Rivacor Aura DR-T 482014 | Biotronik, Inc. | Oregon | Approved | PMA 180-day supplement | MRM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000009S120) |
| December 10, 2025 | P950037/S281 | Siello T 53; Siello T 60; Siello JT 45; Siello JT 53; Solia T 53; Solia T 60; Solia JT 45; Solia JT 53... | 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=P950037S281) |
| December 10, 2025 | P070008/S173 | 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=P070008S173) |
| November 26, 2025 | K252405 | Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter | Surgical Instrument Service and Savings, Inc. | Oregon | Substantially Equivalent | 510(k) traditional | NLH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252405) |
| November 12, 2025 | K253290 | XSTAT P15 | Revmedx, Inc. | Oregon | Substantially Equivalent | 510(k) traditional | PGZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253290) |
| October 29, 2025 | P980023/S141 | Pamira S 60 428768 Pamira S 65 428769 Pamira S 75 428770 Pamira SD 60/16 428771 Pamira SD 65/16 428772 Pamira... | 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=P980023S141) |
| October 24, 2025 | P950037/S272 | Edora 8 DR-T; Evity 8 DR-T; Enitra 8 DR-T; Enticos 8 DR-T; Evity 6 DR-T; Enitra 6 DR-T; Edora 8 DR; Enitra 6... | Biotronik, Inc. | Oregon | Approved | PMA 135-day supplement | DXY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P950037S272) |
| October 24, 2025 | P070008/S167 | Edora 8 HF-T QP; Edora 8 HF-T; Evity 8 HF-T QP; Evity 8 HF-T; Enitra 8 HF-T QP; Enitra 8 HF-T; Enticos 8 HF-T... | Biotronik, Inc. | Oregon | Approved | PMA 135-day supplement | NKE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P070008S167) |
| October 24, 2025 | P050023/S196 | Acticor 7 VR-T; Rivacor 7 VR-T; Rivacor 5 VR-T; Rivacor 3 VR-T; Acticor 7 VR-T DX; Rivacor 7 VR-T DX; Rivacor... | Biotronik, Inc. | Oregon | Approved | PMA 135-day supplement | MRM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P050023S196) |
| October 23, 2025 | P210037/S013 | Prospera SCS System; Resilience Percutaneous Lead; Embrace One; TrueLock | Biotronik Nro, Inc. | Oregon | 30-day notice accepted | PMA 30-day notice | LGW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P210037S013) |
| October 17, 2025 | K250145 | Biopsy Port Adapter | Endosound, Inc. | Oregon | Substantially Equivalent | 510(k) traditional | ODC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250145) |
| October 16, 2025 | P980023/S139 | Ilivia Neo 7 VR-T DX 429530; Intica Neo 7 VR-T DX 429559; Intica Neo 5 VR-T DX 429569 | 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=P980023S139) |
| October 16, 2025 | P950037/S278 | 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 | 30-day notice accepted | PMA 30-day notice | DXY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P950037S278) |
| October 16, 2025 | P070008/S171 | 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 | 30-day notice accepted | PMA 30-day notice | NKE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P070008S171) |
| October 16, 2025 | P050023/S203 | 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 | 30-day notice accepted | PMA 30-day notice | MRM | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P050023S203) |
| October 16, 2025 | P000009/S123 | Ilivia Neo 7 DR-T 429529; Intica Neo 7 DR-T 429558; Intica Neo 5 DR-T 429568 | 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=P000009S123) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Biotronik, Inc. | 137 | October 28, 2026 |
| Biotronik Nro, Inc. | 7 | June 5, 2026 |
| Surgical Instrument Service and Savings, Inc. | 6 | December 19, 2025 |
| Riverpoint Medical, LLC | 5 | September 29, 2026 |
| Riverpoint Medical | 5 | August 27, 2026 |
| Acumed, LLC | 4 | August 21, 2025 |
| TZ Medical | 1 | October 29, 2026 |
| Tz Medical, Inc. | 1 | May 22, 2026 |
| Letus Corporation | 1 | March 25, 2026 |
| Revmedx, Inc. | 1 | November 12, 2025 |
| Endosound, Inc. | 1 | October 17, 2025 |
| The Tmj Clinic PC | 1 | September 17, 2025 |
| Narnar, LLC | 1 | July 14, 2025 |
| Brain Electrophysiology Laboratory Company, LLC | 1 | April 10, 2025 |
| Dci International, LLC | 1 | February 19, 2025 |
| Surgical Instrument Service and Savings Inc.(Dba Medline Ren | 1 | November 15, 2024 |

## By panel

| Panel | Decisions | Latest |
| --- | --- | --- |
| [Cardiovascular](https://specstream.ai/data/fda-clearances/panel/cardiovascular) | 145 | October 28, 2026 |
| [Orthopedic](https://specstream.ai/data/fda-clearances/panel/orthopedic) | 11 | August 27, 2026 |
| [Neurology](https://specstream.ai/data/fda-clearances/panel/neurology) | 8 | June 5, 2026 |
| [General, Plastic Surgery](https://specstream.ai/data/fda-clearances/panel/general-plastic-surgery) | 4 | September 29, 2026 |
| [Dental](https://specstream.ai/data/fda-clearances/panel/dental) | 2 | September 17, 2025 |
| [Obstetrics/Gynecology](https://specstream.ai/data/fda-clearances/panel/obstetrics-gynecology) | 1 | October 29, 2026 |
| Unknown | 1 | March 25, 2026 |
| [Gastroenterology, Urology](https://specstream.ai/data/fda-clearances/panel/gastroenterology-urology) | 1 | October 17, 2025 |
| [Radiology](https://specstream.ai/data/fda-clearances/panel/radiology) | 1 | July 14, 2025 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [PMA 30-day notice](https://specstream.ai/data/fda-clearances/decision/pma-30-day-notice) | 82 | October 28, 2026 |
| [PMA real-time process supplement](https://specstream.ai/data/fda-clearances/decision/pma-real-time-process-supplement) | 29 | October 9, 2026 |
| [PMA 180-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-180-day-supplement) | 24 | October 16, 2026 |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 21 | October 29, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 9 | September 29, 2026 |
| [PMA special supplement](https://specstream.ai/data/fda-clearances/decision/pma-special-supplement) | 4 | October 1, 2025 |
| [PMA 135-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-135-day-supplement) | 3 | October 24, 2025 |
| [510(k) abbreviated](https://specstream.ai/data/fda-clearances/decision/510k-abbreviated) | 2 | September 17, 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/).