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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 NEUROSTIMULATION (IPG) SYSTEM
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024
PMA NumberP010032
Supplement NumberS013
Date Received12/16/2004
Decision Date05/11/2005
Product Codes LGW GZB 
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 THE ADDITION OF FOUR MODELS OF THE S-SERIES LAMITRODE LEADS AS ACCESSORIES TO THE GENESIS FAMILY OF NEUROSTIMULATION IPG DEVICES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME S-SERIES LAMITRODE LEADS (MODEL NUMBERS3243, 3246, 3283 AND 3286) AND IS INDICATED FOR USE AS THE LEAD COMPONENT OF A SPINAL CORD STIMULATION SYSTEM. THE SPINAL CORD STIMULATION SYSTEM IS USED TO AID IN THE MANAGEMENT OF CHRONIC PAIN OF THE TRUNK AND/OR EXTREMITIES.
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