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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, GENESIS RC, GENESIS XP AND THE EON NEUROSTIMULATION SYSTEMS
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantAbbott Medical
6901 Preston Road
Plano, TX 75024
PMA NumberP010032
Supplement NumberS020
Date Received03/21/2007
Decision Date06/11/2007
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 THE USE OF THE TRIPOLE 8, TRIPOLE 8C, TRIPOLE 16C, AND EXCLAIM 8 LAMITRODE SERIES LEADS (MODELS 3208, 3210, 3214, 3224) WITH THE GENESIS, GENESIS RC, GENESIS XP, AND EON NEUROSTIMULATION SYSTEMS, WHICH ARE INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN.
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