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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.
Classification Nametissue graft of 6mm and greater
Generic Namevascular graft prosthesis of animal origin
PMA NumberN16837
Supplement NumberS020
Date Received04/01/2015
Decision Date04/29/2015
Product Code
LXA[ Registered Establishments with LXA ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes to the instructions for use brochure including: 1) change the size labeling convention from outer to inner diameter; and 2) the addition of an information statement not made with natural rubber latex.