Singapore HSA registration DE0508548
Medtronic SenSight™ Directional Lead System
Singapore·CLASS D·Medtronic, Inc.·Registered October 06, 2023Device classification
- Device Class
- CLASS D
- Medical Speciality Area
- Neurology
Registration information
- Registration Number
- DE0508548
- Registration Date
- October 06, 2023
- Change Notification Approval Date
- April 14, 2025
- Retention Due Date
- October 05, 2025
Product description
The lead is an implanted device intended to conduct electrical stimulation to the intended target as part of a DBS system. Medtronic DBS Therapy for Movement Disorders is indicated (i) 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. (ii) 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. Medtronic DBS System for Epilepsy is 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.
Product Owner
- Name
- Medtronic, Inc.
- Short Name
- Medtronic, Inc.
- Address
- 710 Medtronic Parkway, 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)
- Clinician Programmer SenSight Burr Hole Device SenSight Depth Stop and Cranial Tunneler Kit SenSight Lead Cap Kit SenSight Extension Tunneler Kit SenSight Connector Plug SenSight Burr Hole Device Kit SenSight Directional Lead Kit SenSight Directional Lead Kit SenSight Directional Lead Kit SenSight Directional Lead Kit SenSight Directional Lead Kit SenSight Directional Lead Kit SenSight Directional Lead Kit SenSight Directional Lead Kit SenSight Extension Kit SenSight Extension Kit SenSight Extension Kit SenSight Extension Kit SenSight Extension Kit SenSight Extension Kit
- Model Identifier(s)
- A610 B31000 B31010 B31020 B31030 B31061 B32000 B3300533 B3300533M B3300542 B3300542M B3301533 B3301533M B3301542 B3301542M B3400040 B3400040M B3400060 B3400060M B3400095 B3400095M
About this record
Access comprehensive regulatory information for Medtronic SenSight™ Directional Lead 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 DE0508548 and owned by Medtronic, Inc.. The device was registered on October 06, 2023.
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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