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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nameendovascular graft and delivery system
ApplicantCOOK, INC.
PMA NumberP020018
Date Received05/24/2002
Decision Date05/23/2003
Product Code
MIH[ Registered Establishments with MIH ]
Docket Number 03M-0242
Notice Date 07/11/2003
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S013 S014 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S025 S026 S027 S029 
S030 S031 S032 S033 S034 S036 S037 S038 S039 
S040 S041 S042 S043 S044 S045 S046 S047 S048 
S049 S050 S052 S053 
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