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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceZENITH FENESTRATED AAA ENDOVASCULAR GRAFT
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantCOOK, INC.
750 Daniels Way
P.O. Box 489
Bloomington, IN 47402
PMA NumberP020018
Supplement NumberS040
Date Received10/07/2011
Decision Date04/04/2012
Product Code MIH 
Docket Number 12M-0371
Notice Date 04/17/2012
Advisory Committee Cardiovascular
Clinical TrialsNCT00875563
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? Yes
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT (WITH THE ADJUNCTIVE ZENITH ALIGNMENT STENT). THE ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT IS INDICATED FOR THE ENDOVASCULAR TREATMENT OFPATIENTS WITH ABDOMINAL AORTIC OR AORTOILIAC ANEURYSMS HAVING MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR, INCLUDING: 1) ADEQUATE ILIAC/FEMORAL ACCESS COMPATIBLE WITH REQUIRED INTRODUCTION SYSTEMS;2) NONANEURYSMAL INFRARENAL AORTIC SEGMENT (NECK) PROXIMAL TO THE ANEURYSMS WITH: A) LENGTH >= 4 MM AND UNSUITABLE FOR A NON-FENESTRATED GRAFT. B) DIAMETER <= 31 MM AND >= 19 MM. C) ANGLE < 45 DEGREES RELATIVE TO LONG AXIS OF ANEURYSM. D) ANGLE < 45 DEGREES RELATIVE TO AXIS OF SUPRARENAL AORTA. 3) IPSILATERAL ILIAC ARTERY FIXATION SITE > 30 MM IN LENGTH AND BETWEEN 9 - 21 MM IN DIAMETER; AND CONTRALATERAL ILIAC ARTERY DISTAL FIXATION SITE > 30 MM IN LENGTH AND BETWEEN 7 - 21 MM IN DIAMETER. THE ZENITH ALIGNMENT STENT IS INDICATED FOR USE AS AN ADJUNCT TO THE ZENITH FENESTRATED AAAENDOVASCULAR GRAFT TO SECURE POSITIVE ALIGNMENT OF FENESTRATIONS OR SCALLOPS WITH THE ORIFICE OF AORTIC BRANCH VESSELS HAVING DIAMETERS RANGING FROM 3 TO 8 MM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
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