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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.
 
DevicePROTEGE NEUROSTIMULATION SYSTEM
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Namestimulator, spinal-cord, totally implanted for pain relief
Applicant
St. Jude Medical
6901 preston road
plano, TX 75024
PMA NumberP010032
Supplement NumberS079
Date Received04/15/2014
Decision Date07/14/2014
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR RAPID PROGRAMMER VERSION 3.6 TO SUPPORT THEPROGRAMMING OF THE PROTÉGÉ NEUROSTIMULATION DEVICES (MODEL 3789 PROTÉGÉ IMPLANTABLE PULSE GENERATOR AND MODEL 3852 PATIENT PROGRAMMER) AS WELL AS TO MAKE MINOR SUSTAINING ENHANCEMENTS.
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