PMA P020018S006

Device
ZENITH AAA ENDOVASCULAR GRAFT
Applicant
Cook, Inc.
PMA number
P020018
Supplement
S006
Product code
MIH
Decision date
2005-06-14
Classification
System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
ALTERNATIVE SUPPLIER OF WOVEN POLYESTER FABRIC.

Current openFDA PMA Record#

Device
ZENITH AAA ENDOVASCULAR GRAFT
Applicant
Cook, Inc.
PMA number
P020018
Supplement
S006
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2005-06-14
Decision code
OK30
Date received
2005-05-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ALTERNATIVE SUPPLIER OF WOVEN POLYESTER FABRIC.