PMA N16837S020

Device: ARTEGRAFT COLLAGEN VASCULAR GRAFT
Applicant: LeMaitre Vascular, Inc.
PMA number: N16837
Supplement: S020
Product code: LXA
Decision date: 2015-04-29
Classification: Tissue Graft Of 6mm And Greater
Generic name: Tissue graft of 6mm and greater
Approval order statement: APPROVAL FOR LABELING CHANGES TO THE INSTRUCTIONS FOR USE BROCHURE INCLUDING: 1) CHANGE THE SIZE LABELING CONVENTION FROM OUTER TO INNER DIAMETER; AND 2) THE ADDITION OF AN INFORMATION STATEMENT NOT MADE WITH NATURAL RUBBER LATEX.

Current openFDA PMA Record#

Device: ARTEGRAFT COLLAGEN VASCULAR GRAFT
Applicant: LeMaitre Vascular, Inc.
PMA number: N16837
Supplement: S020
Product code: LXA
Generic name: Tissue graft of 6mm and greater
Decision date: 2015-04-29
Decision code: APPR
Date received: 2015-04-01
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR LABELING CHANGES TO THE INSTRUCTIONS FOR USE BROCHURE INCLUDING: 1) CHANGE THE SIZE LABELING CONVENTION FROM OUTER TO INNER DIAMETER; AND 2) THE ADDITION OF AN INFORMATION STATEMENT NOT MADE WITH NATURAL RUBBER LATEX.