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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 NameNEUROSTIMULATION SYSTEMS FOR SPINAL CORD STIMULATION (SCS)
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Applicant MEDTRONIC INC.
PMA NumberP840001
Supplement NumberS267
Date Received03/31/2014
Decision Date04/30/2014
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 to provide corrections to the labeling related to the cycling feature (alternating between therapy off and on) in some neurostimulation devices used for spinal cord stimulation and deep brain stimulation.
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