Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | 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 8299 CENTRAL AVE., N.E. SPRING LAKE PARK, MN 55432-3576 |
PMA Number | P790018 |
Supplement Number | S041 |
Date Received | 11/19/2001 |
Decision Date | 04/23/2002 |
Withdrawal Date
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12/23/2011 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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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