PMA P170030S058
- Device
- Orsiro Mission Sirolimus Eluting Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P170030
- Supplement
- S058
- Product code
- NIQ
- Decision date
- 2026-06-11
- Classification
- Cardiovascular
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- 1) additional of 4.5 and 5.0 mm diameter stents to the Orsiro Mission product matrix, and 2) manufacturing changes
Current openFDA PMA Record#
- Device
- Orsiro Mission Sirolimus Eluting Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P170030
- Supplement
- S058
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2026-06-11
- Decision code
- APPR
- Date received
- 2025-06-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- 1) additional of 4.5 and 5.0 mm diameter stents to the Orsiro Mission product matrix, and 2) manufacturing changes