PMA P170030S024
- Device
- Orsiro Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P170030
- Supplement
- S024
- Product code
- NIQ
- Decision date
- 2022-07-27
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Addition of alternative packaging verification testing.
Current openFDA PMA Record#
- Device
- Orsiro Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P170030
- Supplement
- S024
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2022-07-27
- Decision code
- OK30
- Date received
- 2022-06-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of alternative packaging verification testing.