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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 (DBS) EXTENSION KITS
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP960009
Supplement NumberS134
Date Received12/12/2011
Decision Date02/03/2012
Product Code MHY 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR REMOVAL OF THE TUNNELING TOOL AND TUNNELING TOOL ACCESSORIES FROM DEEP BRAIN STIMULATION (DBS) EXTENSION KITS, MODELS 7472A AND 37085.
Post-Approval StudyShow Report Schedule and Study Progress
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