PMA P170030S012
- Device
- Orsiro Sirolimus Eluting Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P170030
- Supplement
- S012
- Product code
- NIQ
- Decision date
- 2020-11-13
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Revisions to production documents and removal of specific process controls that are subsequently repeated during the manufacturing process.
Current openFDA PMA Record#
- Device
- Orsiro Sirolimus Eluting Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P170030
- Supplement
- S012
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2020-11-13
- Decision code
- OK30
- Date received
- 2020-10-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Revisions to production documents and removal of specific process controls that are subsequently repeated during the manufacturing process.