ATS OPEN PIVOT BILEAFLET HEART VALVE
FDA premarket approval P990046/S004 · decided 2001-06-14
Approval details
- PMA number
- P990046
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ATS OPEN PIVOT BILEAFLET HEART VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Ats Medical, Inc.
- Date received
- 2001-03-26
- Decision date
- 2001-06-14
- Days to decision
- 80 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR A SHELF LIFE EXTENSION FROM 3 YEARS TO 5 YEARS.
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