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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.
 
DeviceRESTORE ULTRA NEUROSTIMULATOR, RESTORE SENSOR NEUROSTIMULATOR, ITREL 4 NEUROSTIMULATOR AND ENTERNAL NEUROSTIMULATOR
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMedtronic Neuromodulation
7000 Central Ave. N.E
Minneapolis, MN 55432
PMA NumberP840001
Supplement NumberS234
Date Received02/07/2013
Decision Date06/19/2013
Product Code LGW 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR FIRMWARE CHANGES INTENDED TO CORRECT DEVICE BEHAVIORS THAT RESULT IN TEMPORARY LOSS OF STIMULATION (EXCEPTION BIT) AND CAN AFFECT PROGRAMMED STIMULATION PARAMETERS (OVER-DISCHARGE).
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