PMA P170030S064
- Device
- Orsiro Mission larger diameter stents Ø 4.5 5.0 mm
- Applicant
- Biotronik AG
- PMA number
- P170030
- Supplement
- S064
- Product code
- NIQ
- Decision date
- 2026-07-23
- Classification
- Cardiovascular
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- extension of device shelf life to 24 months
Current openFDA PMA Record#
- Device
- Orsiro Mission larger diameter stents Ø 4.5 5.0 mm
- Applicant
- Biotronik AG
- PMA number
- P170030
- Supplement
- S064
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2026-07-23
- Decision code
- APPR
- Date received
- 2026-04-24
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- extension of device shelf life to 24 months