OPEN PIVOT HEART VALVE, OPEN PIVOT AORTIC VALVED GRAFT, OPEN PIVOT HEART VALVE-APEX, OPEN PIVOT HEART VALVE-AP360
FDA premarket approval P990046/S042 · decided 2016-02-12
Approval details
- PMA number
- P990046
- Supplement
- S042
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- OPEN PIVOT HEART VALVE, OPEN PIVOT AORTIC VALVED GRAFT, OPEN PIVOT HEART VALVE-APEX, OPEN PIVOT HEART VALVE-AP360
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Ats Medical, Inc.
- Date received
- 2015-10-30
- Decision date
- 2016-02-12
- Days to decision
- 105 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval to implement leaflet angle design specifications, an in-process inspection for leaflet angle, and modify the magnetic resonance labeling.
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