FDA.reportPublic FDA data

PMA P140016S001

Device
Zenith Alpha Thoracic Endovascular Graft
Applicant
Cook Medical Incorporated
PMA number
P140016
Supplement
S001
Product code
MIH
Decision date
2017-07-28
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
Approval to remove blunt thoracic aortic injury from the indications for use and remove references to the smaller diameter grafts that have been removed from the market.

Current openFDA PMA Record#

Device
Zenith Alpha Thoracic Endovascular Graft
Applicant
Cook Medical Incorporated
PMA number
P140016
Supplement
S001
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2017-07-28
Decision code
APPR
Date received
2017-06-28
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval to remove blunt thoracic aortic injury from the indications for use and remove references to the smaller diameter grafts that have been removed from the market.