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Terminal/Device DB/Percept PC Deep Brain Stimulator
dbsPMA-approvedapproved

Percept PC Deep Brain Stimulator

Implant Type
dbs
Electrodes
4
Channels
4
FDA Status
PMA-approved
Clinical Stage
Post-market (FDA PMA approved July 2020)
Status
approved
About

The Medtronic Percept PC is the first FDA-approved deep brain stimulation system with bidirectional sensing capability — it both delivers therapeutic electrical stimulation to deep brain structures and simultaneously records local field potentials (LFP) via BrainSense technology. This enables clinicians to detect beta-band oscillations associated with Parkinson's motor symptoms and log them over time for personalized programming. The neurostimulator is implanted in the chest, connected by leads to electrodes in the subthalamic nucleus or globus pallidus. The Percept RC rechargeable version was approved in 2023.

Target Conditions
Parkinson's diseaseessential tremorepilepsyOCD
Milestones
1997-01Medtronic Activa DBS FDA approved for essential tremor
2002-01DBS approved for Parkinson's disease
2020-07Percept PC with BrainSense LFP recording FDA approved
2023-03Percept RC rechargeable version approved
FDA Regulatory Pathway
No FDA Regulatory Status

This device does not have a current FDA designation. It may be a research tool, preclinical device, or consumer product not subject to FDA medical device regulation.

FDA Device Regulatory Guidance ↗
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