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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.
 
DeviceSMART AND SMART CONTROL VASCULAR STENT SYSTEM
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantCordis US Corporation
14201 NW 60th Avenue
Miami Lakes, FL 33014
PMA NumberP120002
Supplement NumberS006
Date Received12/19/2014
Decision Date07/31/2015
Product Code NIP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT NDC, COSTA RICA, S.R.L., EL COYOL ALAJUELA, COSTA RICA, A CONTRACT MANUFACTURER FOR CORDISSMART AND SMART CONTROL NITINOL STENT SYSTEMS.
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