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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.
 
DeviceITREL 4 IMPLANTABLE NEUROSTIMULATION SYSTEM
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMEDTRONIC NEUROMODULATION
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432
PMA NumberP840001
Supplement NumberS211
Date Received04/05/2012
Decision Date05/30/2012
Product Code LGW 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR ITREL 4 NEUROSTIMULATORS, MODELS 37703 AND 37704. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ITREL 4 NEUROSTIMULATORS, MODELS 37703 AND 37704 AND ARE INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE PAIN OFTHE 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;7) PERIPHERAL CAUSALGIA; 8) EPIDURAL FIBROSIS; 9) ARACHNOIDITIS OR LUMBAR ADHESIVE ARACHNOIDITIS; 10) COMPLEX REGIONAL PAIN SYNDROME (CRPS);11) REFLEX SYMPATHETIC DYSTROPHY (RSD), OR 11) CAUSALGIA.
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