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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.
 
DeviceDeep Brain Stimulation Therapy System for Parkinson's Disease
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP960009
Supplement NumberS357
Date Received08/05/2019
Decision Date09/04/2019
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the Changes Being Effected (CBE) for the Deep Brain Stimulation Therapy System for Parkinson's Disease. The changes being effected include changes to Medtronic DBS Therapy physician and patient labeling, to enhance and harmonize the information regarding the risks of depression, suicide ideation, and suicide across the device type.
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