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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.
 
DeviceSURGIKOS ARTIGRAFT
Generic NameTissue graft of 6mm and greater
ApplicantLeMaitre Vascular, Inc.
63 Second Ave.
Burlington, MA 01803
PMA NumberN16837
Supplement NumberS001
Date Received06/29/1979
Decision Date08/01/1979
Product Code LXA 
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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