PMA N16837S034

Device: Artegraft Collagen Vascular Graft
Applicant: LeMaitre Vascular, Inc.
PMA number: N16837
Supplement: S034
Product code: LXA
Decision date: 2024-10-17
Classification: Cardiovascular
Generic name: Tissue graft of 6mm and greater
Approval order statement: implementation of a larger mixing vessel for the sterilization solution, incorporation of microbial filtration of sterilization solution, and expansion of a cleanroom area

Current openFDA PMA Record#

Device: Artegraft Collagen Vascular Graft
Applicant: LeMaitre Vascular, Inc.
PMA number: N16837
Supplement: S034
Product code: LXA
Generic name: Tissue graft of 6mm and greater
Decision date: 2024-10-17
Decision code: OK30
Date received: 2024-09-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: implementation of a larger mixing vessel for the sterilization solution, incorporation of microbial filtration of sterilization solution, and expansion of a cleanroom area