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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.
 
DeviceMEDTRONIC DBS THERAPY FOR PARKINSON'S DISEASE
Generic NameStimulator, electrical, implanted, for parkinsonian symptoms
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP960009
Supplement NumberS229
Date Received05/21/2015
Decision Date11/17/2015
Product Code NHL 
Advisory Committee Neurology
Clinical TrialsNCT00354133
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MODIFICATION TO THE INDICATION FOR USE (IFU) FOR THE MEDTRONIC DEEP BRAIN STIMULATION (BDS) THERAPY FOR PARKINSON¿S DISEASE AND CORRESPONDING LABELING CHANGES ASSOCIATED WITH THE IFU MODIFICATION. BILATERAL STIMULATION OF THE INTERNAL GLOBUS PALLIDUS (GPI) OR THE SUBTHALAMIC NUCLEUS (STN) USING MEDTRONIC DBS THERAPY FOR PARKINSON'S DISEASE IS INDICATED FOR ADJUNCTIVE THERAPY IN REDUCING SOME OF THE SYMPTOMS IN INDIVIDUALS WITH LEVODOPA-RESPONSIVE PARKINSON'S DISEASE OF AT LEAST 4 YEARS¿ DURATION THAT ARE NOT ADEQUATELY CONTROLLED WITH MEDICATION.
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