PMA N16837S012

Device
ARTEGRAFT COLLAGEN VASCULAR GRAFT
Applicant
LeMaitre Vascular, Inc.
PMA number
N16837
Supplement
S012
Product code
LXA
Decision date
2014-03-28
Classification
Tissue Graft Of 6mm And Greater
Generic name
Tissue graft of 6mm and greater
Approval order statement
ALTERNATE SUPPLIER FOR THE BOVINE CAROTID ARTERY.

Current openFDA PMA Record#

Device
ARTEGRAFT COLLAGEN VASCULAR GRAFT
Applicant
LeMaitre Vascular, Inc.
PMA number
N16837
Supplement
S012
Product code
LXA
Generic name
Tissue graft of 6mm and greater
Decision date
2014-03-28
Decision code
OK30
Date received
2014-02-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ALTERNATE SUPPLIER FOR THE BOVINE CAROTID ARTERY.