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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameATS OPEN PIVOT BILEAFLET AORTIC VALVED GRAFT
Classification Nameheart-valve, mechanical
Generic Namereplacement heart valve
ApplicantATS MEDICAL, INC.
PMA NumberP990046
Supplement NumberS005
Date Received09/24/2001
Decision Date06/07/2002
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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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