PMA N16837S010

Device: ARTEGRAFT COLLEGEN VASCULAR GRAFT
Applicant: LeMaitre Vascular, Inc.
PMA number: N16837
Supplement: S010
Product code: LXA
Decision date: 2013-02-25
Classification: Tissue Graft Of 6mm And Greater
Generic name: Tissue graft of 6mm and greater
Approval order statement: APPROVAL FOR THE ADDITION OF MAVERICK BIOSCIENCES PTY LTD AS AN ALTERNATE SUPPLIER OR SOURCE OF THE BOVINE CAROTID ARTERY IN ARTEGRAFT COLLAGEN VASCULAR GRAFT.

Current openFDA PMA Record#

Device: ARTEGRAFT COLLEGEN VASCULAR GRAFT
Applicant: LeMaitre Vascular, Inc.
PMA number: N16837
Supplement: S010
Product code: LXA
Generic name: Tissue graft of 6mm and greater
Decision date: 2013-02-25
Decision code: APPR
Date received: 2012-09-24
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE ADDITION OF MAVERICK BIOSCIENCES PTY LTD AS AN ALTERNATE SUPPLIER OR SOURCE OF THE BOVINE CAROTID ARTERY IN ARTEGRAFT COLLAGEN VASCULAR GRAFT.