PMA N16837S011

Device
ARTEGRAFT BOVINE HETEROGRAFT
Applicant
LeMaitre Vascular, Inc.
PMA number
N16837
Supplement
S011
Product code
LXA
Decision date
2013-12-23
Classification
Tissue Graft Of 6mm And Greater
Generic name
Tissue graft of 6mm and greater
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED IN NORTH BRUNSWICK, NEW JERSEY.

Current openFDA PMA Record#

Device
ARTEGRAFT BOVINE HETEROGRAFT
Applicant
LeMaitre Vascular, Inc.
PMA number
N16837
Supplement
S011
Product code
LXA
Generic name
Tissue graft of 6mm and greater
Decision date
2013-12-23
Decision code
APPR
Date received
2013-04-26
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED IN NORTH BRUNSWICK, NEW JERSEY.