Medtronic SenSight™ Directional Lead System - HSA Registration DE0508548
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.
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.