|
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 | S032 |
Date Received | 08/15/2023 |
Decision Date | 09/19/2023 |
Product Code |
LXA |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Additional service supplier to perform routine sterility testing and bioburden testing on the Artegraft Collagen Vascular Graft. |