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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.
 
DeviceARTEGRAFT COLLAGEN VASCULAR GRAFT
Generic NameTissue graft of 6mm and greater
ApplicantLeMaitre Vascular, Inc.
63 Second Ave.
Burlington, MA 01803
PMA NumberN16837
Supplement NumberS020
Date Received04/01/2015
Decision Date04/29/2015
Product Code LXA 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR LABELING CHANGES TO THE INSTRUCTIONS FOR USE BROCHURE INCLUDING: 1) CHANGE THE SIZE LABELING CONVENTION FROM OUTER TO INNER DIAMETER; AND 2) THE ADDITION OF AN INFORMATION STATEMENT NOT MADE WITH NATURAL RUBBER LATEX.
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