MEDTRONIC HALL AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT, MODEL Z7700, AND MEDTRONIC HALL ROTATABLE AORTIC VALVED COLL0
FDA premarket approval P790018/S041 · decided 2002-04-23
Approval details
- PMA number
- P790018
- Supplement
- S041
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC HALL AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT, MODEL Z7700, AND MEDTRONIC HALL ROTATABLE AORTIC VALVED COLL0
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Cardiac Surgery
- Date received
- 2001-11-19
- Decision date
- 2002-04-23
- Days to decision
- 155 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR A CHANGE TO THE COUNTRY OF ORIGIN FOR THE COLLAGEN USED IN THESE PRODUCTS. THE INTENT OF THE CHANGE IS TO SOURCE THE COLLAGEN FROM A COUNTRY THAT IS FREE FROM BOVINE SPONGIFORM ENCEPHALOPATHY (BSE).
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