MEDTRONIC(R) HALL PROSTHETIC HEART VALVE
FDA premarket approval P790018/S026 · decided 1995-12-07
Approval details
- PMA number
- P790018
- Supplement
- S026
- 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
- 1995-11-01
- Decision date
- 1995-12-07
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR 100% ETO STERILIZATION
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