PMA P170030S016
- Device
- Orsiro Sirolimus Eluting Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P170030
- Supplement
- S016
- Product code
- NIQ
- Decision date
- 2021-05-06
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Modification to the ethylene oxide sterilization parameters.
Current openFDA PMA Record#
- Device
- Orsiro Sirolimus Eluting Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P170030
- Supplement
- S016
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2021-05-06
- Decision code
- OK30
- Date received
- 2021-04-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification to the ethylene oxide sterilization parameters.