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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 NameEXTERNAL NEUROSTIMULATOR,ITREL4,ITREL4X,RESTORE PRIME,PRIMEADVANCED,RESTORE,RESTORE ULTRA,RESTORE ADVANCED & SENSOR
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Applicant MEDTRONIC INC.
PMA NumberP840001
Supplement NumberS227
Date Received09/10/2012
Decision Date10/10/2012
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Use of the new automated assembly equipment controller software release, interfacing with the manufacturing execution system at the hybrid component supplier.
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