PMA P170030S020
- Device
- ORSIRO Mission Sirolimus Eluting Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P170030
- Supplement
- S020
- Product code
- NIQ
- Decision date
- 2021-12-09
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Implementation of the reorganization of lot release changes.
Current openFDA PMA Record#
- Device
- ORSIRO Mission Sirolimus Eluting Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P170030
- Supplement
- S020
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2021-12-09
- Decision code
- OK30
- Date received
- 2021-11-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of the reorganization of lot release changes.