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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 BOVINE HETEROGRAFT
Classification Nametissue graft of 6mm and greater
Generic Namevascular graft prosthesis of animal origin
ApplicantARTEGRAFT, INC.
PMA NumberN16837
Supplement NumberS003
Date Received07/29/1999
Decision Date02/11/2000
Product Code
LXA[ Registered Establishments with LXA ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of a manufacturing site located at artegraft, inc. , north brunswick nj.
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