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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 ACTIVA DEEP BRAIN STIMULATION (DBS) SYSTEMS MODELS 3387S, 3389S DBS LEADS
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP960009
Supplement NumberS036
Date Received12/28/2005
Decision Date03/02/2006
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 MODIFICATIONS TO THE MODEL 3387/3398 DBS LEAD KIT INTENDED FOR USE WITH THE MEDTRONIC IMPLANTABLE SYSTEMS FOR DBS. THE MODIFICATIONS SPECIFIED WERE: TO REMOVE THE PERCUTANEOUS EXTENSION, TO ADD A LEAD CAP, AND TO BUNDLE THE MEDTRONIC IMAGE-GUIDED NEUROLOGICS STIMLOC KIT (BURR HOLE COVER ASSEMBLY) WITH THE DBS LEAD KIT.
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