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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 NumberS001
Date Received01/25/2019
Decision Date03/26/2019
Product Code MIH 
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of the protocol for the post-approval study (PAS) protocol.
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