ATS OPEN PIVOT BILEAFLET HEART VALVES
FDA premarket approval P990046/S013 · decided 2007-08-16
Approval details
- PMA number
- P990046
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ATS OPEN PIVOT BILEAFLET HEART VALVES
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Ats Medical, Inc.
- Date received
- 2004-09-01
- Decision date
- 2007-08-16
- Days to decision
- 1079 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR 22/25 MM MITRAL VALVES, MODELS 501DM22, 503DM22 AND 500DM25.
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