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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.
 
DeviceS.M.A.R.T.® and S.M.A.R.T.® CONTROL® Vascular Stent Systems; S.M.A.R.T. RADIANZ™ Vascular Stent System
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantCordis US Corporation
14201 NW 60th Ave.
Miami Lakes, FL 33014
PMA NumberP120002
Supplement NumberS034
Date Received12/10/2025
Decision Date01/08/2026
Product Code NIP 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval to change the receiving inspection level for 15 part numbers
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