- Device
- 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 Sky HF-T QP,
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S300
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2026-10-28
- Decision code
- OK30
- Date received
- 2026-09-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to implement updates to the final acceptance testing workflow for the Amvia/Solvia family of pacemakers and CRT-Ps