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 | SJM MASTERS SERIES AORTIC VALVED PROSTHESIS WITH VASCUTEK GELWEAVE VALSALVA GRAFT (MODEL VAVGJ-515) |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | Abbott Medical 177 County Road B. East St. Paul, MN 55117 |
PMA Number | P810002 |
Supplement Number | S058 |
Date Received | 01/03/2005 |
Decision Date | 02/14/2005 |
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 AN ADDITIONAL CONFIGURATION OF THE AORTIC VALVED GRAFT USING THE SJM MASTERS SERIES AORTIC VALVED PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SJM MASTERS SERIES AORTIC VALVED PROSTHESIS WITH VASCUTEK GELWEAVE VALSALVA GRAFT (MODEL VAVGJ-515) AND IS INDICATED FOR THE REPLACEMENT OF A MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC HEART VALVE AND ASCENDING AORTA. |
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