PMA P170030S008
- Device
- Orsiro Sirolimus Eluting Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P170030
- Supplement
- S008
- Product code
- NIQ
- Decision date
- 2020-08-20
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- Addition of identical ultrasonic cleaning machines and updates to the cleaning parameters.
Current openFDA PMA Record#
- Device
- Orsiro Sirolimus Eluting Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P170030
- Supplement
- S008
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2020-08-20
- Decision code
- OK30
- Date received
- 2020-07-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of identical ultrasonic cleaning machines and updates to the cleaning parameters.