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Device | ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | COOK MEDICAL INCORPORATED Sandet 6 Bjaeverskov 4632 |
PMA Number | P140016 |
Date Received | 08/13/2014 |
Decision Date | 09/15/2015 |
Product Code |
MIH |
Docket Number | 15M-3377 |
Notice Date | 10/15/2015 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01151020undefined
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Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH 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 Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S011 S012 S013 |