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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 NameRESTOREPRIME & PRIMEADVANCED IMPLANTABLE NEUROSTIMULATORS
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Applicant MEDTRONIC INC.
PMA NumberP840001
Supplement NumberS144
Date Received12/23/2009
Decision Date01/21/2010
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Increase in the press force used to form the battery cathodes which will reduce the cathode thickness variation and increase the yield of the rx1 battery production.
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