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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 FOR USE IN PERIPHERAL VASCULAR SUR
Classification Nametissue graft of 6mm and greater
Generic Nameumbilical cord graft
ApplicantMEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
PMA NumberP780002
Supplement NumberS001
Date Received03/12/1981
Decision Date07/10/1981
Product Code
LXA[ Registered Establishments with LXA ]
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
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