PMA P170030S003
- Device
- Orsiro Sirolimus Eluting Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P170030
- Supplement
- S003
- Product code
- NIQ
- Decision date
- 2019-08-29
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Approval for test protocols addressing the bench-top performance testing.
Current openFDA PMA Record#
- Device
- Orsiro Sirolimus Eluting Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P170030
- Supplement
- S003
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2019-08-29
- Decision code
- APPR
- Date received
- 2019-04-17
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for test protocols addressing the bench-top performance testing.