PMA P170030S004
- Device
- Orsiro Sirolimus Eluting Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P170030
- Supplement
- S004
- Product code
- NIQ
- Decision date
- 2019-10-25
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Changes to the drug-substance manufacturing process.
Current openFDA PMA Record#
- Device
- Orsiro Sirolimus Eluting Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P170030
- Supplement
- S004
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2019-10-25
- Decision code
- OK30
- Date received
- 2019-09-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the drug-substance manufacturing process.