PMA P170030S057
- Device
- Orsiro Mission Sirolimus Eluting Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P170030
- Supplement
- S057
- Product code
- NIQ
- Decision date
- 2025-07-10
- Classification
- Cardiovascular
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- the introduction of a new hardware control logic unit for process ovens used in the manufacture of your coronary and peripheral stent systems
Current openFDA PMA Record#
- Device
- Orsiro Mission Sirolimus Eluting Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P170030
- Supplement
- S057
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2025-07-10
- Decision code
- OK30
- Date received
- 2025-06-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the introduction of a new hardware control logic unit for process ovens used in the manufacture of your coronary and peripheral stent systems