PMA P170030S011
- Device
- ORSIRO Sirolimus Eluting Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P170030
- Supplement
- S011
- Product code
- NIQ
- Decision date
- 2020-10-30
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- ORSIRO Sirolimus Eluting Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P170030
- Supplement
- S011
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2020-10-30
- Decision code
- APPR
- Date received
- 2020-10-02
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.