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Trade Name | Activa® Dystonia Therapy System, Percept™ PC BrainSense™ |
Classification Name | implanted subcortical electrical stimulator (motor disorders) |
Generic Name | implanted subcortical electrical stimulator (motor disorders) |
Applicant |
MEDTRONIC NEUROMODULATION |
7000 central avenue ne |
rcw 225 |
minneapolis, MN 55432 |
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HDE Number | H020007 |
Supplement Number | S360 |
Date Received | 01/29/2024 |
Decision Date | 04/09/2024 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a minor design change to a radio frequency (rf) pin diode of the telemetry-m (tel-m) communication circuit and consequent minor change to the printed circuit board (pcb) used on the intellis 8880t2 (clinician telemetry module, ctm2), 97745 / 97745fa (programmer patient therapy manager, ptm3), and 97745nt (programmer patient therapy manager, ptm3 no bluetooth). |