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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 KINETRA MODEL 7428 IMPLANTABLE NEUROSTIMULATION SYSTEM
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP960009
Supplement NumberS027
Date Received08/27/2002
Decision Date12/16/2003
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 MEDTRONIC KINETRA MODEL 7428 IMPLANTABLE NEUROSTIMULATION SYSTEM WHICH INCLUDES THE MODEL 7428 KINETRA NEUROSTIMULATOR, MODEL 7436 ACCESS THERAPY CONTROLLER, MODEL 8840 N'VISION PROGRAMMER, MODEL 8870 SOFTWARE APPLICATION CARD, MODEL 7459 MEMORYMOD SOFTWARE CARTRIDGE, AND MODEL 3550-09 ACCESSORY KIT. THESE ARE REVISIONS TO THE EXISTING MEDTRONIC ACTIVA PARKINSON'S CONTROL THERAPY ALSO KNOWN AS THE ACTIVA SYSTEM. THE MEDTRONIC KINETRA MODEL 7428 IMPLANTABLE NEUROSTIMULATION SYSTEM IS ONLY INDICATED FOR BILATERAL STIMULATION OF THE INTERNAL GLOBUS PALLIDUS (GPI) OR THE SUBTHALAMIC NUCLEUS (STN) AS AN ADJUNCTIVE THERAPY IN REDUCING SOME OF THE SYMPTOMS OF ADVANCED, LEVODOPA-RESPONSIVE PARKINSON'S DISEASE THAT ARE NOT ADEQUATELY CONTROLLED WITH MEDICATION. ADDITIONALLY, THIS SUPPLEMENT ALSO INCORPORATES THE LATEST MAGNETIC RESONANCE IMAGING (MRI) LABELING INFORMATION WITH RESPECT TO THE ABOVE SYSTEMS.
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