FDA.reportPublic FDA data

PMA P020018S049

Device
ZENITH AAA ENDOVASCULAR GRAFT
Applicant
Cook, Inc.
PMA number
P020018
Supplement
S049
Product code
MIH
Decision date
2013-04-24
Classification
System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
APPROVAL FOR CHANGES TO THE MANUFACTURING AND QUALITY CONTROL PROCEDURES TO PROVIDE ADDITIONAL INSPECTION STEPS REGARDING THE PROXIMAL BARB ALIGNMENT WITH THE TOP CAP SIDE HOLE AND BARB SOLDERING SPECIFICATION FOR THE DEVICE.

Current openFDA PMA Record#

Device
ZENITH AAA ENDOVASCULAR GRAFT
Applicant
Cook, Inc.
PMA number
P020018
Supplement
S049
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2013-04-24
Decision code
APPR
Date received
2013-03-26
Supplement type
Special (Immediate Track)
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR CHANGES TO THE MANUFACTURING AND QUALITY CONTROL PROCEDURES TO PROVIDE ADDITIONAL INSPECTION STEPS REGARDING THE PROXIMAL BARB ALIGNMENT WITH THE TOP CAP SIDE HOLE AND BARB SOLDERING SPECIFICATION FOR THE DEVICE.