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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 MRI NEUROSTIMULATION SYSTEM
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Nameimplantable pulse generator system
ApplicantST. JUDE MEDICAL
PMA NumberP010032
Supplement NumberS085
Date Received09/29/2014
Decision Date04/22/2015
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the protege mri ipg model 3 771 and patient programmer (ppgr) model 3853 which have updated labeling that will allow patients to undergo mri scans of the head and extremities per the defined conditions.
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