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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceITREL 4 IMPLANTABLE NEUROSTIMULATION SYSTEM
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Namestimulator, spinal-cord, totally implanted for pain relief
Applicant
MEDTRONIC NEUROMODULATION
7000 central avenue ne
minneapolis, MN 55432
PMA NumberP840001
Supplement NumberS211
Date Received04/05/2012
Decision Date05/30/2012
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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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