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 | MEDTRONIC ACTIVA TREMOR CONTROL 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 | S246 |
Date Received | 02/08/2016 |
Decision Date | 04/21/2016 |
Product Code |
MHY |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes made to the Model 8840 N'Vision® Clinician Programmer including replacement of PCBA components, liquid crystal display assembly changes, compact flash card housing and programmer housing design changes, infrared data association transceiver changes, static random access memory changes, electromagnetic interference shield changes, telemetry module platform software updates, clinical programmer base module platform software updates, Physician Manual labeling changes, EMC Declaration changes, device labeling changes and packaging labeling changes. |
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