• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections

New Search Back to Search Results
Classification Namesystem, endovascular graft, aortic aneurysm treatment
PMA NumberP140016
Date Received08/19/2014
Decision Date09/15/2015
Product Code
MIH[ Registered Establishments with MIH ]
Docket Number 15M-3377
Notice Date 10/15/2015
Advisory Committee Cardiovascular
Clinical Trials NCT01151020undefined
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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; and 2) nonaneurysmal aortic segments (fixation sites) proximal and distal to the thoracic lesion: a) with a length of at least 20 mm; and b) 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
Post-Approval StudyShow Report Schedule and Study Progress