• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade Name36 MM DIAMETER ZENITH FLEX AAA ENDOVASCULAR GRAFT
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Nameendovascular graft and delivery system
ApplicantCOOK, INC.
PMA NumberP020018
Supplement NumberS010
Date Received06/05/2006
Decision Date09/07/2006
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the 36 mm diameter zenith flex aaa endovascular graft.
Post-Approval StudyShow Report Schedule and Study Progress
-
-