PMA P020018S040

Device

ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT

Applicant

Cook, Inc.

PMA number

P020018

Supplement

S040

Product code

MIH

Decision date

2012-04-04

Classification

System, Endovascular Graft, Aortic Aneurysm Treatment

Generic name

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

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.

Summary

<a href="http://www.accessdata.fda.gov/cdrh_docs/pdf2/P020018S040B.pdf" target="_new">Summary of Safety and Effectiveness</a>