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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceDARDIK BIOGRAFT
Generic NameTissue graft of 6mm and greater
ApplicantSYNOVIS SURGICAL INNOVATIONS
2575 UNIVERSITY AVE. WEST
ST. PAUL, MN 55114-1024
PMA NumberP780002
Date Received06/12/1978
Decision Date01/17/1979
Withdrawal Date 12/13/2007
Product Code LXA 
Notice Date 07/24/1979
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Supplements:  S001 S002 S004 S005 S008 S012 
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