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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 NameDARDIK BIOGRAFT
Classification Nametissue graft of 6mm and greater
Generic Nameumbilical cord graft
ApplicantSYNOVIS SURGICAL INNOVATIONS
PMA NumberP780002
Date Received06/12/1978
Decision Date01/17/1979
Withdrawal Date 12/13/2007
Product Code
LXA[ Registered Establishments with LXA ]
Notice Date 07/24/1979
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S004 S005 S008 S012 
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