- Device
- Solia T 53, Solia T 60, Solia S 45, Solia S 53, Solia S 60, Solia CSP S 53, Solia CSP S 60
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S295
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2026-07-01
- Decision code
- OK30
- Date received
- 2026-06-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to implement an alternate manufacturing site for coils used as conductors in BIOTRONIK cardiac rhythm management leads