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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 THERAPY FOR DEEP BRAIN STIMULATION
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP960009
Supplement NumberS042
Date Received09/17/2007
Decision Date10/17/2007
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
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR TE ADDITION OF A PRECAUTION TO PATIENT MANUALS OF THE MODEL 7436 AND MODEL 7438 THERAPY CONTROLLERS.
Post-Approval StudyShow Report Schedule and Study Progress
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