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. |
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Device | Activa Deep Brain Stimulation Therapy System |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S332 |
Date Received | 11/21/2018 |
Decision Date | 02/12/2019 |
Product Codes |
MBX MHY NHL PJS |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the Maintenance Release 1 Update to the Model A610 Activa DBS Clinician Programmer Application which updated the impedance measurement workflow, enabled interleaving programming in both hemispheres, and updated reports. |
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