- Device
- Amvia Edge DR-T, Amvia Edge SR-T, Amvia Sky DR-T, Amvia Sky SR-T, Solvia Rise DR-T, Solvia Rise SR-T, Amvia Edge HF-T QP
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S266
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2024-12-06
- Decision code
- OK30
- Date received
- 2024-11-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- reduction to the current incoming inspection level for certain raw materials