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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 NumberS010
Date Received04/26/2021
Decision Date05/26/2021
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  
Implementation of a change in raw material and its supplier for the body of the Stopcock-Luer Cap Assembly of INCRAFT AAA Stent Graft delivery system.
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