CDSCO UID IMP/MD/2021/000380_d2ff87c502257e262ddefc3bb88a3a98_a63b7349a926828c9b4685600910ee0c

Multi-program Neurostimulator

India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India·Device Class Class D·India CDSCO·Brand: Activa PC
Registration details
UID
IMP/MD/2021/000380_d2ff87c502257e262ddefc3bb88a3a98_a63b7349a926828c9b4685600910ee0c
Device class
Class D
Brand name
Activa PC
Approving authority
CDSCO
Product information
Medtronic® DBS Therapy for Epilepsy Bilateral anterior thalamic nucleus (Activa PC) 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. Medtronic® DBS Therapy for Movement Disorders Medtronic DBS Therapy for Movement Disorders is indicated for stimulation of the ventral intermediate nucleus (Activa PC) for patients with disabling essential tremor or Parkinsonian tremor, or stimulation of the internal globus pallidus (Activa PC) or the subthalamic nucleus (Activa PC) 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 (Activa PC) or the subthalamic nucleus (Activa PC) as an aid in the management of chronic, intractable (Activa PC) primary dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (Activa PC) for individuals 7 years of age and older
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India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India
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Brand: Activa PC
India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India
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About this record

Multi-program Neurostimulator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000380_d2ff87c502257e262ddefc3bb88a3a98_a63b7349a926828c9b4685600910ee0c. This device is marketed under the brand name Activa PC. The license holder is India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India, and it is classified as Device Class Class D. The approving authority is CDSCO.

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