# Biotronik, Inc.: PMA supplement approved for PSW 2601.U, NEO 2601.U, Amvia Sky HF-T QP, Amvia Sky HF-T, Amvia Edge HF-T QP, Amvia Sky D

**Score:** 30/100

| Field | Value |
|---|---|
| Sponsor | Biotronik, Inc. |
| Product | 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 SR-T, Amvia Edg |
| Generic / ingredient | implantable pacemaker Pulse-generator |
| Approval | PMA supplement (device change) |
| Application | P950037 S291 |
| Decided | 2026-09-17 |
| Panel / class | Cardiovascular |
| Sponsor location | Lake Oswego, OR |

## Why this score


Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P950037S291). Last refreshed: 2026-11-04T06:06:18.796Z.
From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.