Pure Global

Neurostimulator - India CDSCO Medical Device Registration

Neurostimulator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000040_bb4ef57e2e191a52c7bffa792fbd73af_e732bc955e94bb26176ebba01a460133. This device is marketed under the brand name Ascenda. The license holder is India Medtronic Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database
Powered by Pure Global AI
CDSCO Registered
Class Class D
Neurostimulator
UID: IMP/MD/2019/000040_bb4ef57e2e191a52c7bffa792fbd73af_e732bc955e94bb26176ebba01a460133

Brand Name

Ascenda

Device Class

Class D

Approving Authority

CDSCO

Product Information

Medtronic DBS Therapy for Movement Disorders is indicated for stimulation of the ventral intermediate nucleus (Ascenda) for patients with disabling essential tremor or Parkinsonian tremor, or stimulation of the internal globus pallidus (Ascenda) or the subthalamic nucleus (Ascenda) for patients with symptoms of Parkinson's disease. Studies have shown that deep brain stimulation with the Medtronic DBS Therapy system is effective in controlling essential tremor and symptoms of Parkinson's disease that are not adequately controlled with medications. Additionally, deep brain stimulation is effective in controlling dyskinesias and fluctuations associated with medical therapy for Parkinson's disease. Medtronic DBS Therapy for Movement Disorders is also indicated for stimulation of the internal globus pallidus (Ascenda) or the subthalamic nucleus (Ascenda) as an aid in the management of chronic, intractable (Ascenda) primary dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (Ascenda) for individuals 7 years of age and older. Medtronicยฎ DBS Therapy for Epilepsy Bilateral anterior thalamic nucleus (Ascenda) stimulation using the 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

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing