MEDTRONIC(R) HALL PROSTHETIC HEART VALVE AND VALVED CONDUITS
FDA premarket approval P790018/S024 · decided 1996-05-13
Approval details
- PMA number
- P790018
- Supplement
- S024
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC(R) HALL PROSTHETIC HEART VALVE AND VALVED CONDUITS
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Cardiac Surgery
- Date received
- 1995-01-18
- Decision date
- 1996-05-13
- Days to decision
- 481 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE USE OF OCCLUDERS MADE BY MEDTRONIC CARBON IMPLANTS (MCI) OF AUSTIN, TEXAS, AS A COMPONENT OF THE MEDTRONIC HALL PROSTHETIC HEART VALVE AND VALVED CONUITS, MODELS A7700, M7700, C7700, AND Z7700
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