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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 HEART VALVE
Classification Nameheart-valve, mechanical
Generic Namereplacement heart valve
ApplicantATS MEDICAL, INC.
PMA NumberP990046
Supplement NumberS007
Date Received06/11/2003
Decision Date08/01/2003
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a cuff design change. The device, as modified, will be marketed under the trade name ats open pivot bileaflet heart valve, apex aortic models 503da16, 503da18, 503da20, 503da22, 503da24, 503da26, and 503da28, and apex mitral models 503dm24, 503dm26, and 503dm28 and is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves.
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