PMA P170030
- Device
- ORSIRO Sirolimus Eluting Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P170030
- Supplement
- S026
- Product code
- NIQ
- Decision date
- 2026-08-07
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Post Approval Study Protocol for the EVO Extended Diameter PAS
Current openFDA PMA Record#
- Device
- ORSIRO Sirolimus Eluting Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P170030
- Supplement
- S065
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2026-08-07
- Decision code
- APPR
- Date received
- 2026-07-10
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Post Approval Study Protocol for the EVO Extended Diameter PAS