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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 NumberS092
Date Received12/19/2014
Decision Date07/09/2015
Product Code LGW 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ST. JUDE MEDICAL INVISIBLE TRIAL SYSTEM COMPRISING OF THE FOLLOWING DEVICES:1) ST. JUDE MEDICAL EXTERNAL PULSE GENERATOR (EPG), 16 CHANNEL: MODEL 3599; 2) ST. JUDE MEDICAL CLINICIAN PROGRAMMER APP (CP): MODEL 3870;3) ST. JUDE MEDICAL PATIENT CONTROLLER APP (PC): MODEL 3871; AND 4) ASSOCIATED ACCESSORIES (LEAD MODELS 3046, 3066, AND 3086 AND MULTI-LEAD TRIAL CABLE (MLTC) 3013).THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ST. JUDE MEDICAL INVISIBLE TRIAL SYSTEM AND IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH ANY OF THE FOLLOWING: FAILED BACK SURGERY SYNDROME AND INTRACTABLE LOW BACK AND LEG PAIN. THE ST. JUDE MEDICAL INVISIBLE NEUROMODULATION TRIAL SYSTEM IS INTENDED TO BE USED EXTERNALLY WITH ST. JUDE MEDICAL APPROVED TRIAL LEADS AND EXTENSIONS TO DELIVER TRIAL STIMULATION FOR A MAXIMUM OF 30 DAYS.
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