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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 TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantWILLIAM COOK EUROPE APS
SANDET 6, DK-4632
BJAEVERSKOV 
PMA NumberP070016
Date Received07/02/2007
Decision Date05/21/2008
Withdrawal Date 02/24/2020
Product Code MIH 
Docket Number 08M-0311
Notice Date 05/27/2008
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM. THIS DEVICE IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF PATIENTS WITH ANEURYSMS OR ULCERS OF THE DESCENDING THORACIC AORTA HAVING VASCULAR MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR, INCLUDING: 1) ADEQUATE ILIAC/FEMORAL ACCESS COMPATIBLE WITH THE REQUIRED INTRODUCTION SYSTEMS; AND 2) NON-ANEURYSMAL AORTIC SEGMENTS (FIXATION SITES) PROXIMAL AND DISTAL TO THE ANEURYSM OR ULCER: A) WITH A LENGTH OF AT LEAST 25 MM; AND B) WITH A DIAMETER MEASURED OUTER WALL TO OUTER WALL OF NO GREATER THAN 38 MM AND NO LESS THAN 24 MM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S007  S005 S006 S004 S010 S009 S002 S003 S001 
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