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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.
 
DeviceRESTORESENSOR RECHARGABLE IMPLANTABLE NEUROSTIMULATION SYSTEM
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMEDTRONIC NEUROMODULATION
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432
PMA NumberP840001
Supplement NumberS185
Date Received05/16/2011
Decision Date11/03/2011
Product Code LGW 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE RESTORESENSOR RECHARGEABLE IMPLANTABLE NEUROSTIMULATION SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RESTORESENSOR RECHARGEABLE IMPLANTABLE NEUROSTIMULATION SYSTEM AND IS INDICATED FOR SPINAL CORD STIMULATION (SCS) AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THE FOLLOWING CONDITIONS:1) FAILED BACK SYNDROME (FBS) OR LOW BACK SYNDROME OR FAILED BACK; 2) RADICULAR PAIN SYNDROME OR RADICULOPATHIES RESULTING IN PAIN SECONDARY TO FBS OR HERNIATED DISK; 3) POSTLAMINECTOMY PAIN; 4) MULTIPLE BACK OPERATIONS; 5) UNSUCCESSFUL DISK SURGERY; 6) DEGENERATIVE DISK DISEASE (DDD)/HERNIATED DISK PAIN REFRACTORY TO CONSERVATIVE AND SURGICAL INTERVENTIONS; 5) PERIPHERAL CAUSALGIA; 6) EPIDURAL FIBROSIS; 7) ARACHNOIDITIS OR LUMBAR ADHESIVE ARACHNOIDITIS; AND 8) COMPLEX REGIONAL PAIN SYNDROME (CRPS), REFLEX SYMPATHETIC DYSTROPHY (RSD), OR CAUSALGIA.
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