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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 NameBIOPOLYMERIC(TM) VASCULAR GRAFT
Classification Nametissue graft of 6mm and greater
Generic Nametissue graft of 6mm and greater
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP800058
Supplement NumberS015
Date Received01/23/1993
Decision Date10/25/1994
Product Code
LXA[ Registered Establishments with LXA ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
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