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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceATS OPEN PIVOT BILEAFLET AORTIC VALVED GRAFT
Generic NameHEART-VALVE, MECHANICAL
ApplicantMEDTRONIC ATS MEDICAL, INC.
3800 ANNAPOLIS LANE, SUITE 175
PLYMOUTH, MN 55447
PMA NumberP990046
Supplement NumberS005
Date Received09/24/2001
Decision Date06/07/2002
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO COMBINE THE ATS OPEN PIVOT BILEAFLET HEART VALVE (APPROVED ON OCTOBER 13, 2000 UNDER P990046) WITH THE MEADOX HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT (APPROVED ON MAY 11, 1993 UNDER P840029/S005). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ATS OPEN PIVOT BILEAFLET AORTIC VALVED GRAFT, MODELS 502AG21 THROUGH 502AG29, AND IS INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES, WHERE A REPLACEMENT VALVE AND REPLACEMENT OR REPAIR OF THE AORTA IS REQUIRED.
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