PMA N16837S030

Device: Artegraft Collagen Vascular Graft
Applicant: LeMaitre Vascular, Inc.
PMA number: N16837
Supplement: S030
Product code: LXA
Decision date: 2023-04-25
Classification: Cardiovascular
Generic name: Tissue graft of 6mm and greater
Approval order statement: Addition of two new alternative service suppliers to perform water testing and environmental testing for manufacturing of the Artegraft Collagen Vascular Graft.

Current openFDA PMA Record#

Device: Artegraft Collagen Vascular Graft
Applicant: LeMaitre Vascular, Inc.
PMA number: N16837
Supplement: S030
Product code: LXA
Generic name: Tissue graft of 6mm and greater
Decision date: 2023-04-25
Decision code: OK30
Date received: 2023-03-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of two new alternative service suppliers to perform water testing and environmental testing for manufacturing of the Artegraft Collagen Vascular Graft.