- Device
- Orsiro Mission Sirolimus Eluting Coronary Stent System; Synsiro Pro Sirolimus Eluting Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P170030
- Supplement
- S055
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2025-08-19
- Decision code
- APPR
- Date received
- 2025-05-21
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval to introduce an additional trade name, Synsiro Pro, for the approved PMA device.