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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePROCOL VASCULAR BIOPROSTHESIS
Generic NameTissue graft of 6mm and greater
ApplicantLEMAITRE VASCULAR INC
63 SECOND AVENUE
BURLINGTON, MA 01803
PMA NumberP020049
Supplement NumberS002
Date Received02/22/2010
Decision Date03/23/2010
Withdrawal Date 12/15/2023
Product Code LXA 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ADDITION OF A NEW DISTRIBUTION SITE.
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