|Trade Name||37751 RECHARGE CHARGING SYSTEM|
|Classification Name||stimulator, spinal-cord, totally implanted for pain relief|
|Generic Name||stimulator, spinal-cord, totally implanted for pain relief|
|Supplement Type||special (immediate track)|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for labeling changes to the manuals for the model 37751 recharge charger system, the information for prescribers manual - medtronic dbs therapy, and the information for prescribers manual- medtronic pain therapy using neurostimulation for chronic pain. These changes include the addition of precautions related to recharger use, modification of the device, and the effect of electromagnetic interference (emi) on telemetry communication.