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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 NameDARDIK BIOGRAFT(R) MOD. HUMAN UMBILICAL VEIN GRAFT
Classification Nametissue graft of 6mm and greater
Generic Namehuman umbilical vein
ApplicantBIO-VASCULAR, INC.
PMA NumberP780002
Supplement NumberS012
Date Received09/08/1995
Decision Date11/24/1995
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
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