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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 | S019 |
Date Received | 03/06/2015 |
Decision Date | 04/04/2016 |
Product Code |
LXA |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the use of new polymers for the button and rod that are used in the primary packaging system for this device. |