• 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 NameTRIVASCULAR, INC OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
ApplicantTRIVASCULAR INC
PMA NumberP120006
Supplement NumberS006
Date Received08/26/2013
Decision Date09/24/2013
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
New vendor of the resin material for the molded luer components in the fill polymer kit.
-
-