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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
Classification Nametissue graft of 6mm and greater
Generic Nameumbilical cord graft
ApplicantMEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
PMA NumberP780002
Supplement NumberS004
Date Received11/12/1981
Decision Date11/30/1981
Product Code
LXA[ Registered Establishments with LXA ]
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
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