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. |
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Device | ARTEGRAFT COLLAGEN VASCULAR GRAFT |
Generic Name | Tissue graft of 6mm and greater |
Applicant | LeMaitre Vascular, Inc. 63 Second Avenue Burlington, MA 01803 |
PMA Number | N16837 |
Supplement Number | S021 |
Date Received | 09/11/2015 |
Decision Date | 01/19/2016 |
Product Code |
LXA |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR INCLUDING A NON-ANTIGENIC STATEMENT IN THE INSTRUCTIONS FOR USE. |
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