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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/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.
 
DeviceZENITH ALPHA THORACIC ENDOVASCULAR GRAFT
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantCOOK MEDICAL INCORPORATED
Sandet 6
Bjaeverskov 4632
PMA NumberP140016
Date Received08/13/2014
Decision Date09/15/2015
Product Code MIH 
Docket Number 15M-3377
Notice Date 10/15/2015
Advisory Committee Cardiovascular
Clinical TrialsNCT01151020undefined
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT. THIS DEVICE IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF PATIENTS WITH ISOLATED LESIONS OF THE DESCENDING THORACIC AORTA (NOT INCLUDING DISSECTIONS) HAVING VASCULAR ANATOMY SUITABLE FOR ENDOVASCULAR REPAIR, INCLUDING:1) ILIAC/FEMORAL ANATOMY THAT IS SUITABLE FOR ACCESS WITH THE REQUIRED INTRODUCTION SYSTEMS; AND2) NONANEURYSMAL AORTIC SEGMENTS (FIXATION SITES) PROXIMAL AND DISTAL TO THE THORACIC LESION:A) WITH A LENGTH OF AT LEAST 20 MM; ANDB) WITH A DIAMETER MEASURED OUTER WALL TO OUTER WALL OF NO GREATER THAN 42 MM AND NO LESS THAN 15 MM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S011 S012 
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