PMA P950037S297
- Device
- Solia CSP S
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S297
- Product code
- DXY
- Decision date
- 2026-08-27
- Classification
- Cardiovascular
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- improvements for laser welding processes
Current openFDA PMA Record#
- Device
- Solia CSP S
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S297
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2026-08-27
- Decision code
- OK30
- Date received
- 2026-07-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- improvements for laser welding processes