- Device
- ORSIRO Sirolimus Eluting Coronary Stent System and Orsiro Mission Sirolimus Eluting Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P170030
- Supplement
- S021
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2022-02-23
- Decision code
- OK30
- Date received
- 2022-01-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Using an alternative vacuum oven for the annealing of the drug-coated Orsiro and Orsiro Mission Stents.