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 | MECHANICAL HEART VALVE, MASTERS SERIES COATED AORTIC VALVED GRAFT, MODEL CAVGJ-514 00 |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | Abbott Medical 177 County Road B. East St. Paul, MN 55117 |
PMA Number | P810002 |
Supplement Number | S056 |
Date Received | 03/26/2001 |
Decision Date | 05/03/2001 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE COUNTRY OF ORIGIN OF THE BOVINE COLLAGEN USED FOR THE HEMASHIELD(R) GRAFT, WHICH IS A COMPONENT OF THE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ST. JUDE MEDICAL(R) MECHANICAL HEART VALVE - MASTER SERIES COATED AORTIC VALVED GRAFT, MODEL CAVGJ-51400 IN SIZES 19, 21, 23, 25, 27, 29, 31, AND 33 MM, AND IS INDICATED FOR THE REPLACEMENT OF THE AORTIC VALVE AND THE ASCENDING AORTA. |
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