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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 Road
Plano, TX 75024
PMA NumberP010032
Supplement NumberS009
Date Received11/12/2003
Decision Date01/20/2004
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 AXXESS PERCUTANEOUS LEAD MODELS 4143, 4146, 4153 AND 4156 WITH THE ANS GENESIS NEUROSTIMULATION (IPG) MODEL 3608, THE ANS GENESIS XP NEUROSTIMULATION (IPG) MODEL 3609, THE ANS GENESIS DUAL XP NEUROSTIMULATION (IPG) MODEL 3644 AND THE ANS GENESIS G4 NEUROSTIMULATION (IPG) MODEL 3604 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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