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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. RADIANZ™ Vascular Stent System
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantCordis US Corporation
14201 NW 60th Ave.
Miami Lakes, FL 33014
PMA NumberP120002
Supplement NumberS021
Date Received10/28/2022
Decision Date04/20/2023
Product Code NIP 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-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 for the removal of an in-process test (pod elongation test), during manufacturing of the POD Subassembly.
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