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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.
 
Trade Name37751 RECHARGE CHARGING SYSTEM
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Applicant MEDTRONIC INC.
PMA NumberP840001
Supplement NumberS210
Date Received04/04/2012
Decision Date04/20/2012
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product 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.
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