MEDTRONIC(R) HALL PROSTHETIC HEART VALVE
FDA premarket approval P790018/S031 · decided 1997-11-24
Approval details
- PMA number
- P790018
- Supplement
- S031
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC(R) HALL PROSTHETIC HEART VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Cardiac Surgery
- Date received
- 1997-07-21
- Decision date
- 1997-11-24
- Days to decision
- 126 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for a modification to the controlled environment area for certain manufacturing steps.
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