• 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
 


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.
 
DeviceVALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Namesystem, endovascular graft, aortic aneurysm treatment
Applicant
Medtronic Vascular
3576 unocal place
santa rosa, CA 95403
PMA NumberP100040
Supplement NumberS008
Date Received04/30/2012
Decision Date10/26/2012
Product Code
MIH[ Registered Establishments with MIH ]
Docket Number 12M-1109
Notice Date 11/08/2012
Advisory Committee Cardiovascular
Clinical Trials NCT00413231
NCT01092767
NCT01114724
NCT01181947
NCT01213589
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the valiant thoracic stent graft with the captivia delivery system. This device is indicated for the endovascular repair of isolated lesions (excluding dissections) of the descending thoracic aorta in patients having appropriate anatomy, including: iliac or femoral artery access vessel morphology that is compatible with vascular access techniques, devices, or accessories; nonaneurysmal aortic diameter in the range of 18 to 42 mm (fusiform and saccular aneurysms/ penetrating ulcers) or 18 mm to 44 mm (blunt traumatic aortic injuries); and nonaneurysmal aortic proximal and distal neck lengths >= 20 mm.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
-
-