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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 RC RECHARGEABLE IMPLANTABLE NEUROSTIMULATION SYSTEM
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP960009
Supplement NumberS051
Date Received04/24/2008
Decision Date03/27/2009
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 THE FOLLOWING NEW COMPONENTS AND ACCESSORIES FOR THE ACTIVA RCRECHARGEABLE IMPLANTABLE NEUROSTIMULATION SYSTEM:¿ ACTIVA RC, MODEL 37612 (NEUROSTIMULATOR)¿ PATIENT PROGRAMMER, MODEL 37642¿ MODEL 8870 APPLICATION CARD (ACTIVA RC)¿ EXTERNAL NEUROSTIMULATOR, MODEL 37022¿ 8-4 EXTENSION, MODEL 37085¿ ALLIGATOR CLIP SCREENING CABLE. MODEL 3550-67¿ TWIST LOCK SCREENING CABLE, MODEL 3550-68THE ACTIVA RC RECHARGEABLE IMPLANTABLE NEUROSTIMULATION SYSTEM IS INDICATED AS FOLLOWS:MEDTRONIC ACTIVA THERAPY INCLUDES ACTIVA PARKINSON'S CONTROL THERAPY AND ACTIVA TREMORCONTROL THERAPY.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, LEVODOPA-RESPONSIVE PARKINSON'S DISEASE THAT ARE NOT ADEQUATELY CONTROLLED WITH MEDICATION.TREMOR CONTROL THERAPY UNILATERAL THALAMIC STIMULATION BY THE MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM IS INDICATEDFOR 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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