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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Trade NameN.C.G.T. GRAFT
Classification Nametissue graft of 6mm and greater
Generic Namevascular graft, bovine
PMA NumberP800058
Date Received10/03/1980
Decision Date09/08/1981
Withdrawal Date 12/03/2007
Product Code
LXA[ Registered Establishments with LXA ]
Docket Number 81M-0307
Notice Date 10/23/1981
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S003 S005 S006 S007 S008 S011 S014 S015