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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.
 
DeviceGENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantAbbott Medical
6901 Preston Road
Plano, TX 75024
PMA NumberP010032
Supplement NumberS090
Date Received12/15/2014
Decision Date03/04/2015
Product Code LGW 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A DESIGN CHANGE TO THE STYLET MODELS THAT ARE USED WITHSJM SCS SYSTEMS; SPECIFICALLY, COATING THE STYLETS WITH A PFOA-FREE PTFE, RESULTING IN GENERATION 3 OF THE STYLETS. THIS SUPPLEMENT ALSO REQUESTED APPROVAL FOR A MANUFACTURING CHANGE TO TIGHTEN THE TOLERANCES ON THE TOOLING MANDREL USED TO MANUFACTURE THE ASSOCIATED LEAD MODELS.
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