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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 Ave.
Burlington, MA 01803
PMA NumberP020049
Supplement NumberS003
Date Received07/11/2014
Decision Date09/29/2014
Withdrawal Date12/15/2023
Product Code LXA 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED IN IRVINE, CALIFORNIA.
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