- Device
- OPEN PIVOT HEART VALVE, OPEN PIVOT AORTIC VALVED GRAFT, OPEN PIVOT HEART VALVE-APEX, OPEN PIVOT HEART VALVE-AP360
- Applicant
- Medtronic Ats Medical, Inc.
- PMA number
- P990046
- Supplement
- S042
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2016-02-12
- Decision code
- APPR
- Date received
- 2015-10-30
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval to implement leaflet angle design specifications, an in-process inspection for leaflet angle, and modify the magnetic resonance labeling.