PMA P070016S007

Device: ZENITH TX2 THORACIC ENDOVASCULAR GRAFT
Applicant: William Cook Europe Aps
PMA number: P070016
Supplement: S007
Product code: MIH
Decision date: 2013-05-20
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: APPROVAL FOR UPDATING SEVERAL SECTIONS IN THE IFU REGARDING MAINTAINING HEMOSTASIS, TRIGGER WIRE RELEASE, AND MRI SAFETY INFORMATION.

Current openFDA PMA Record#

Device: ZENITH TX2 THORACIC ENDOVASCULAR GRAFT
Applicant: William Cook Europe Aps
PMA number: P070016
Supplement: S007
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2013-05-20
Decision code: APPR
Date received: 2013-04-23
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR UPDATING SEVERAL SECTIONS IN THE IFU REGARDING MAINTAINING HEMOSTASIS, TRIGGER WIRE RELEASE, AND MRI SAFETY INFORMATION.