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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 NumberS030
Date Received03/28/2023
Decision Date04/25/2023
Product Code LXA 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Addition of two new alternative service suppliers to perform water testing and environmental testing for manufacturing of the Artegraft Collagen Vascular Graft.
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