• 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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceINCRAFT(R) AAA STENT GRAFT SYSTEM
Generic Namesystem, endovascular graft, aortic aneurysm treatment
Applicant
Cordis US Corporation
14201 n.w. 60th avenue
miami lakes, FL 33014
PMA NumberP150002
Supplement NumberS008
Date Received03/31/2020
Decision Date09/23/2020
Product Code MIH 
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - pas
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for updating the labeling to include 5-year INSPIRATION study data and minor editorial changes.
-
-