PMA P170030S061
- Device
- ORSIRO Sirolimus Eluting Coronary Stent System; Synsiro Pro Sirolimus Eluting Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P170030
- Supplement
- S061
- Product code
- NIQ
- Decision date
- 2026-04-01
- Classification
- Cardiovascular
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- the addition of a third pickling line at the stent manufacturing site
Current openFDA PMA Record#
- Device
- ORSIRO Sirolimus Eluting Coronary Stent System; Synsiro Pro Sirolimus Eluting Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P170030
- Supplement
- S061
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2026-04-01
- Decision code
- OK30
- Date received
- 2026-03-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the addition of a third pickling line at the stent manufacturing site