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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 NameARTEGRAFT COLLAGEN VASCULAR GRAFT
Classification Nametissue graft of 6mm and greater
Generic Namevascular graft prosthesis of animal origin
ApplicantARTEGRAFT, INC.
PMA NumberN16837
Supplement NumberS017
Date Received07/30/2014
Decision Date08/25/2014
Product Code
LXA[ Registered Establishments with LXA ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Alternate supplier for the bovine carotid artery.
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