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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 NamePROTEGE SYSTEM
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Nameimplantable pulse generator system
ApplicantST. JUDE MEDICAL
PMA NumberP010032
Supplement NumberS074
Date Received12/23/2013
Decision Date03/21/2014
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling modifications to change the name of the eon mini ipg to protégé (model 3789); labeling modifications to change the name of the eon mini le charge to prodigy charger (model 3730); and minor software modifications to the patient programmer and rapid programmer (model 3852) to recognize the device with the new protégé device name and model number.
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