MEDTRONIC(R) HALL PROSTHETIC HEART VALVE
FDA premarket approval P790018/S030 · decided 1997-09-29
Approval details
- PMA number
- P790018
- Supplement
- S030
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC(R) HALL PROSTHETIC HEART VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Cardiac Surgery
- Date received
- 1997-03-13
- Decision date
- 1997-09-29
- Days to decision
- 200 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for the Rotatable Aortic Valved Collagen Impregnated Conduit (Rotatable AVCIC, Model R7700).
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