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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.
 
DeviceCORDIS S.M.A.R.T. AND S.M.A.R.T. CONTROL VASCULAR STENT SYSTEM
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantCordis US Corporation
14201 NW 60th Ave.
Miami Lakes, FL 33014
PMA NumberP120002
Supplement NumberS011
Date Received10/05/2015
Decision Date11/05/2015
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  
A CHANGE TO THE MANUFACTURING LOCATION OF YOUR SUPPLIER FOR THE INTERNAL PACKAGING POUCHES.
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