PMA P170030S052
- Device
- Orsiro Mission Sirolimus Eluting Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P170030
- Supplement
- S052
- Product code
- NIQ
- Decision date
- 2026-06-05
- Classification
- Cardiovascular
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- the introduction of a new production site for supply of the hypotube and a new hypotube extrusion process
Current openFDA PMA Record#
- Device
- Orsiro Mission Sirolimus Eluting Coronary Stent System
- Applicant
- Biotronik AG
- PMA number
- P170030
- Supplement
- S052
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2026-06-05
- Decision code
- APPR
- Date received
- 2025-03-05
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the introduction of a new production site for supply of the hypotube and a new hypotube extrusion process