• 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 AAA Stent Graft System
Generic Namesystem, endovascular graft, aortic aneurysm treatment
ApplicantCordis US Corporation
14201 n.w. 60th avenue
miami lakes, FL 33014
PMA NumberP150002
Supplement NumberS002
Date Received05/01/2019
Decision Date05/30/2019
Product Code MIH 
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Movement of INCRAFT manufacturing to another building at the same facility and addition of a semi-automated process step during the inner member assembly.
-
-