PMA N16837S035

Device: Artegraft Collagen Vascular Graft
Applicant: LeMaitre Vascular, Inc.
PMA number: N16837
Supplement: S035
Product code: LXA
Decision date: 2024-12-18
Classification: Cardiovascular
Generic name: Tissue graft of 6mm and greater
Approval order statement: implementation of an additional Bacterial Endotoxin Testing Facility and an additional Environmental Monitoring Facility for the Artegraft Collagen Vascular Graft

Current openFDA PMA Record#

Device: Artegraft Collagen Vascular Graft
Applicant: LeMaitre Vascular, Inc.
PMA number: N16837
Supplement: S035
Product code: LXA
Generic name: Tissue graft of 6mm and greater
Decision date: 2024-12-18
Decision code: OK30
Date received: 2024-11-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: implementation of an additional Bacterial Endotoxin Testing Facility and an additional Environmental Monitoring Facility for the Artegraft Collagen Vascular Graft