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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 NumberS077
Date Received12/02/2004
Decision Date04/15/2005
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the synergy plus+ (model 7479) and synergy compact+ (model 7479b) neurostimulation systems which are indicated as an aid in the management of chronic, intractable, unilateral or bilateral pain associated with the following: 1) failed back syndrome or low back syndrome or failed back; 2) radicular pain syndrome or radiculopathies resulting in pain secondary to failed back syndrome; 3) post laminectomy pain; 4) unsuccessful disk surgery; 5) degenerative disk disease (ddd)/herniated disk pain refractory to conservative and surgical interventions; 6) peripheral causalgia; 7) epidural fibrosis; 8) arachnoiditis or lumbar adhesive arachnoiditis; 9) complex regional pain syndrome (crps) or reflex sympathetic dystrophy (rsd) or causalgia; and 10) multiple back surgeries.