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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 NameST JUDE MEDICAL MECHANICAL HEART VALVE
Classification Nameheart-valve, mechanical
Generic Namecoated aortic valved graft
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP810002
Supplement NumberS060
Date Received10/23/2006
Decision Date11/21/2007
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the supplier of the polyester yarn that is used in the fabrication of: 1) the knitted polyester tubular fabric that is the source material from the st. Jude medical mechanical heart valve sewing cuffs, and 2) the hemashield bovine collagen sealed woven polyester vascular graft.
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