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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.
 
DeviceACTIVA TREMOR CONTROL THEREAPY SYSTEM
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP960009
Supplement NumberS019
Date Received07/03/2001
Decision Date12/31/2001
Product Code MHY 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE MODEL 7438 THERAPY CONTROLLER WHICH IS INTENDED TO BE USED AS AN ALTERNATIVE TO THE EXISTING MODEL 7452 CONTROL MAGNET AS A COMPONENT OF THE MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM.
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