PMA N16837S036

Device: Artegraft Collagen Vascular Graft
Applicant: LeMaitre Vascular, Inc.
PMA number: N16837
Supplement: S036
Product code: LXA
Decision date: 2025-06-11
Classification: Cardiovascular
Generic name: Tissue graft of 6mm and greater
Approval order statement: implementation of a larger mixing vessel and associated microbial filtration for the sterilization solution used in manufacturing of the Artegraft Collagen Vascular Graft

Current openFDA PMA Record#

Device: Artegraft Collagen Vascular Graft
Applicant: LeMaitre Vascular, Inc.
PMA number: N16837
Supplement: S036
Product code: LXA
Generic name: Tissue graft of 6mm and greater
Decision date: 2025-06-11
Decision code: OK30
Date received: 2025-05-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: implementation of a larger mixing vessel and associated microbial filtration for the sterilization solution used in manufacturing of the Artegraft Collagen Vascular Graft