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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.
 
Device37751 RECHARGE CHARGING SYSTEM
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP960009
Supplement NumberS142
Date Received04/04/2012
Decision Date04/20/2012
Product Code MHY 
Advisory Committee Neurology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR LABELING CHANGES TO THE MANUALS FOR THE MODEL 37751 RECHARGE CHARGER SYSTEM, THE INFORMATION FOR PRESCRIBERS MANUAL - MEDTRONIC DBS THERAPY, AND THE INFORMATION FOR PRESCRIBERS MANUAL- MEDTRONIC PAIN THERAPY USING NEUROSTIMULATION FOR CHRONIC PAIN. THESE CHANGES INCLUDE THE ADDITION OF PRECAUTIONS RELATED TO RECHARGER USE, MODIFICATION OF THE DEVICE, AND THE EFFECT OF ELECTROMAGNETIC INTERFERENCE (EMI) ON TELEMETRY COMMUNICATION.
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