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PMA P020018S057

Device
ZENITH AAA ENDOVASCULAR GRAFT
Applicant
Cook, Inc.
PMA number
P020018
Supplement
S057
Product code
MIH
Decision date
2016-12-08
Classification
System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
Approval for implementation of an additional in-process inspection step and update to an existing quality control step in the manufacturing of the Zenith AAA Endovascular Graft system.

Current openFDA PMA Record#

Device
ZENITH AAA ENDOVASCULAR GRAFT
Applicant
Cook, Inc.
PMA number
P020018
Supplement
S057
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2016-12-08
Decision code
APPR
Date received
2016-11-09
Supplement type
Special (Immediate Track)
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for implementation of an additional in-process inspection step and update to an existing quality control step in the manufacturing of the Zenith AAA Endovascular Graft system.