PMA P020018S042

Device: ZENITH AAA ENDOVASCULAR GRAFT
Applicant: Cook, Inc.
PMA number: P020018
Supplement: S042
Product code: MIH
Decision date: 2012-04-13
Classification: System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE (IFU) LABELING. THE LABELING CHANGES INVOLVED RECOMMENDATIONS TO USERS REGARDING MAINTAINING HEMOSTASIS, USE OF FLUOROSCOPY AND TRIGGER WIRE RELEASE, AND AN ALTERNATIVE SUPRARENAL DEPLOYMENT SEQUENCE.

Current openFDA PMA Record#

Device: ZENITH AAA ENDOVASCULAR GRAFT
Applicant: Cook, Inc.
PMA number: P020018
Supplement: S042
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2012-04-13
Decision code: APPR
Date received: 2012-01-10
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE (IFU) LABELING. THE LABELING CHANGES INVOLVED RECOMMENDATIONS TO USERS REGARDING MAINTAINING HEMOSTASIS, USE OF FLUOROSCOPY AND TRIGGER WIRE RELEASE, AND AN ALTERNATIVE SUPRARENAL DEPLOYMENT SEQUENCE.