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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 NumberS005
Date Received11/15/2006
Decision Date02/16/2007
Product Code
LXA[ Registered Establishments with LXA ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the primary package and to the shrink seal.
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