ATS OPEN PIVOT BILEAFLET
FDA premarket approval P990046/S006 · decided 2002-05-29
Approval details
- PMA number
- P990046
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- ATS OPEN PIVOT BILEAFLET
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Ats Medical, Inc.
- Date received
- 2002-05-01
- Decision date
- 2002-05-29
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL TO TRANSFER THE MANUFACTURING OF THE PYROLYTIC CARBON COATED HEART VALVE COMPONENTS FROM SULZER CARBOMEDICS, INC., TO ATS MEDICAL INC., MINNEAPOLIS, MINNESOTA.
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