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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 NameN.C.G.T. GRAFT
Classification Nametissue graft of 6mm and greater
Generic Nametissue graft of 6mm and greater
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP800058
Supplement NumberS007
Date Received10/10/1986
Decision Date11/02/1987
Product Code
LXA[ Registered Establishments with LXA ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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