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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 NameRESTORE FAMILY OF NEUROSTIMULATORS
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Applicant MEDTRONIC INC.
PMA NumberP840001
Supplement NumberS159
Date Received08/09/2010
Decision Date04/22/2011
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor design changes to the l283 multi-function integrated circuit contained in the neurostimulators of the device.
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