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Medtronic Percept PC BrainSense DBS System - HSA Registration DE0510268

Access comprehensive regulatory information for Medtronic Percept PC BrainSense DBS System in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0510268 and owned by Medtronic, Inc.. The device was registered on January 21, 2025.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS D
DE0510268
Medtronic Percept PC BrainSense DBS System
HSA Registration Number: DE0510268
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Product Description

The implantable neurostimulator is intended as part of a neurostimulation system for deep brain stimulation. It is indicated for stimulation of the ventral intermediate nucleus (VIM) for patients with disabling essential tremor or Parkinsonian tremor, or stimulation of the internal globus pallidus (GPi), or the subthalamic nucleus (STN) for patients with symptoms of Parkinson's disease and for stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis) for individuals 7 years of age and older. It is also indicated as adjunctive therapy for reducing the frequency of seizures in adults diagnosed with epilepsy characterized by partial- onset seizures, with or without secondary generalization, that are refractory to antiepileptic medications.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Neurology
Registration Information
Registration Number
DE0510268
Registration Date
January 21, 2025
Retention Due Date
January 20, 2026
Product Owner
Short Name
Medtronic, Inc.
Address
710 Medtronic Parkway NE, Minneapolis, MN 55432, UNITED STATES
Registrant
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model Information
Model Name(s)
External Neurostimulator Communicator Clinician App Patient App Connector Plug Percept PC BrainSense Percept PC BrainSense Handset with Communicator Patient Communicator
Model Identifier(s)
37022 8880T2 A610 A620 B31060 B35200 TH91D02 TM91