MEDTRONIC HALL ROTATABLE AORTIC VALVE COLLAGEN IMPREGNATED CONDUIT
FDA premarket approval P790018/S052 · decided 2009-07-09
Approval details
- PMA number
- P790018
- Supplement
- S052
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC HALL ROTATABLE AORTIC VALVE COLLAGEN IMPREGNATED CONDUIT
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Cardiac Surgery
- Date received
- 2009-06-09
- Decision date
- 2009-07-09
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- CHANGES TO THE BIOBURDEN TESTING AND CHANGE TO THE STERILIZATION TEST METHODS.
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