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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 PC IMPLANTABLE NEUROSTIMULATION SYSTEM
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP960009
Supplement NumberS052
Date Received06/06/2008
Decision Date04/07/2009
Product Code MHY 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR NEW ACTIVA PC IMPLANTABLE NEUROSTIMULATION SYSTEM (INS), INTENDED FOR DEEP BRAIN STIMULATION (DBS). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THETRADE NAME ACTIVA PC AND IS INDICATED FOR THE FOLLOWING:PARKINSON'S CONTROL THERAPYBILATERAL STIMULATION OF THE INTERNAL GLOBUS PALLIDUS (GPI) OR THE SUBTHALAMIC NUCLEUS (STN)USING MEDTRONIC ACTIVA PARKINSON'S CONTROL THERAPY IS INDICATED FOR ADJUNCTIVE THERAPY IN REDUCING SOME OF THE SYMPTOMS OF ADVANCED, LEVODOPARESPONSIVE PARKINSON'S DISEASE THAT ARE NOT ADEQUATELY CONTROLLED WITH MEDICATION.TREMOR CONTROL THERAPYUNILATERAL THALAMIC STIMULATION BY THE MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM IS INDICATED FOR THE SUPPRESSION OF TREMOR IN THE UPPER EXTREMITY. THE SYSTEM IS INTENDED FOR USE INPATIENTS WHO ARE DIAGNOSED WITH ESSENTIAL TREMOR OR PARKINSONIAN TREMOR NOT ADEQUATELYCONTROLLED BY MEDICATIONS AND WHERE THE TREMOR CONSTITUTES A SIGNIFICANT FUNCTIONAL DISABILITY.
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