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Multi-program rechargeable neurostimulator - India CDSCO Medical Device Registration

Multi-program rechargeable neurostimulator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000380_d1c23c20784fa8c6e92e021a5023c6c8_7221848f76c150ff51bc125cbde4efa7. 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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CDSCO Registered
Class Class D
Multi-program rechargeable neurostimulator
UID: IMP/MD/2021/000380_d1c23c20784fa8c6e92e021a5023c6c8_7221848f76c150ff51bc125cbde4efa7

Brand Name

Activa PC

Device Class

Class D

Approving Authority

CDSCO

Product Information

Medtronicยฎ 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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