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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 NamePROCOL VASCULAR BIOPROSTHESIS
Classification Nametissue graft of 6mm and greater
ApplicantHANCOCK/JAFFE LABORATORIES
PMA NumberP020049
Supplement NumberS002
Date Received02/22/2010
Decision Date03/23/2010
Product Code
LXA[ Registered Establishments with LXA ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of a new distribution site.
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