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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 NumberS039
Date Received08/06/2026
Decision Date09/04/2026
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 of a new warning and other labeling changes in the Instructions for Use for the Artegraft Collagen Vascular Graft
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