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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceEON MINI AND PROGEGE IMPLANTABLE NEUROSTIMULATION DEVICE
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 NumberS078
Date Received04/08/2014
Decision Date07/07/2014
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 UPDATING FIRMWARE FROM VERSION 3.0 TO VERSION 3.0.1 FOREON MINI (MODEL 3788) AND PROTÉGÉ (MODEL 2789) IMPLANTABLE PULSE GENERATOR THAT ARE USED IN SPINAL CORD STIMULATION THERAPY.
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