MEDTRONIC HALL PROSTHETIC HEART VALVE/EASY-FIT/AORTIC VALVED CONDUIT/COLLAGEN IMPREGNATED CONDUIT/ROTATABLE AORTIC
FDA premarket approval P790018/S050 · decided 2008-12-09
Approval details
- PMA number
- P790018
- Supplement
- S050
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC HALL PROSTHETIC HEART VALVE/EASY-FIT/AORTIC VALVED CONDUIT/COLLAGEN IMPREGNATED CONDUIT/ROTATABLE AORTIC
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Cardiac Surgery
- Date received
- 2008-11-10
- Decision date
- 2008-12-09
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- USE OF A NEW MODEL AIR SAMPLER.
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