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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 Deep Brain Stimulation Therapy System
Generic NameStimulator, electrical, implanted, for parkinsonian tremor
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP960009
Supplement NumberS304
Date Received11/16/2017
Decision Date05/26/2018
Product Codes MBX MHY NHL 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for Medtronics new model A610 Activa Clinician Programmer application and Model 8880T2 Communicator intended for programming DBS systems and for a field-implementable update to the Model 37612 Activa RC implantable neurostimulator to extend the service life from 9 years to 15 years.
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