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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 Rd.
Plano, TX 75024
PMA NumberP010032
Supplement NumberS094
Date Received12/24/2014
Decision Date03/24/2015
Product Code LGW 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MINOR DESIGN CHANGES TO THE 8-CHANNEL ADAPTER (MODELS 2311 AND 2316) TO INTRODUCE A NEW 8-CHANNEL ADAPTER (MODELS 2321 AND 2326) FOR THE SPINAL CORD STIMULATION SYSTEM. THE NEW 8-CHANNEL ADAPTER IS INTENDED TO CONNECT A COMPATIBLE 8-CHANNEL BOSTON SCIENTIFIC LEAD OR EXTENSION TO A COMPATIBLE ST. JUDE MEDICAL IMPLANTABLE PULSE GENERATOR.
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