ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT

FDA Premarket Approval P140016

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.

Pre-market Approval Supplement Details

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.

DeviceZENITH ALPHA THORACIC ENDOVASCULAR GRAFT
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantCOOK MEDICAL INCORPORATED
Date Received2014-08-13
Decision Date2015-09-15
Notice Date2015-10-15
PMAP140016
SupplementS
Product CodeMIH 
Docket Number15M-3377
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address COOK MEDICAL INCORPORATED 750 Daniels Way p.o. Box 489 bloomington, IN 47402-0489
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P140016Original Filing
S005 2022-03-18 Special (immediate Track)
S004 2021-12-03 Special (immediate Track)
S003 2021-06-11 30-day Notice
S002 2020-10-29 Normal 180 Day Track No User Fee
S001 2017-06-28 Special (immediate Track)

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