- Device
- Orsiro Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P170030
- Supplement
- S022
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2022-08-31
- Decision code
- APPR
- Date received
- 2022-03-04
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for the PMA Post-Approval Study Labeling Update for the Orsiro and Orsiro Mission Siolimus Eluting Coronary Stent Systems.