PMA P170030S001
- Device
- Orsiro Sirolimus Eluting Coronary Stent System
- Applicant
- Biotronik AG
- Product code
- NIQ
- Decision date
- 2020-01-23
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Approval for an additional EO sterilizer.
Current openFDA PMA Record#
- Device
- Orsiro Sirolimus Eluting Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P170030
- Supplement
- S001
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2020-01-23
- Decision code
- APPR
- Date received
- 2019-03-18
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an additional EO sterilizer.