Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM
• Generic Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Applicant: Cook, Inc.; 750 Daniels Way; P.O. Box 489; Bloomington, IN 47402
• PMA Number: P020018
• Date Received: 05/24/2002
• Decision Date: 05/23/2003
• Product Code: MIH
• Docket Number: 03M-0242
• Notice Date: 07/11/2003
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No
• Recalls: CDRH Recalls

Approval Order Statement  
APPROVAL FOR THE ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTION SYSTEM. THE DEVICE IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF PATIENTS WITH ABDOMINAL AORTIC OR AORTO-ILIAC ANEURYSMS HAVING MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Supplements: S039 S038 S037 S030 S019 S020 S021 S022 S023 S032 S040 ; S041 S034 S046 S048 S049 S052 S011 S013 S014 S015 S016 S017 ; S018 S005 S024 S003 S004 S029 S001 S002 S008 S027 S007 S056 ; S057 S050 S053 S043 S044 S047 S055 S042 S045 S006 S009 S010 ; S025 S026 S031 S033 S036 S058 S059 S061 S062 S060 S065 S064 ; S066 S063 S067 S068