ATS OPEN PIVOT BILEAFLET HEART VALVE
FDA premarket approval P990046/S003 · decided 2001-05-10
Approval details
- PMA number
- P990046
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ATS OPEN PIVOT BILEAFLET HEART VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Ats Medical, Inc.
- Date received
- 2000-10-20
- Decision date
- 2001-05-10
- Days to decision
- 202 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR VALVE SIZES 16/19 MM AORTIC AND 24/27 MM MITRAL AND THE ADDITION OF A VALVE RESTERILIZATION INSTRUCTION IN THE LABELING.
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