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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.
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Namestimulator, spinal-cord, totally implanted for pain relief
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.