CDSCO UID IMP/MD/2021/000419_d8e90e711e6c46309bcb2be78628e33e_be9af1fb3fa80a2326121ab01c7fcd41
Lead kit for deep brain stimulation
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: Interstim
Registration details
- UID
- IMP/MD/2021/000419_d8e90e711e6c46309bcb2be78628e33e_be9af1fb3fa80a2326121ab01c7fcd41
- Device class
- Class D
- Brand name
- Interstim
- Approving authority
- CDSCO
- Product information
- 3387 (Interstim)- Medtronic® DBS Therapy for Epilepsy Bilateral anterior thalamic nucleus (Interstim) 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 (Interstim) for patients with disabling essential tremor or Parkinsonian tremor, or stimulation of the internal globus pallidus (Interstim) or the subthalamic nucleus (Interstim) for patients with symptoms of Parkinson's disease. Studies have shown that deep brain stimulation with the Medtronic DBS Therapy system is ffective 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 (Interstim) or the subthalamic nucleus (Interstim) as an aid in the management of chronic, intractable (Interstim) primary dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (Interstim) for individuals 7 years of age and older. 3389 (Interstim) Medtronic® DBS Therapy for Movement Disorders Medtronic DBS Therapy for Movement Disorders is indicated for stimulation of the ventral intermediate nucleus (Interstim) for patients with disabling essential tremor or Parkinsonian tremor, or stimulation of the internal globus pallidus (Interstim) or the subthalamic nucleus (Interstim) 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 (Interstim) or the subthalamic nucleus (Interstim) as an aid in the management of chronic, intractable (Interstim) primary dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (Interstim) for individuals 7 years of age and older.
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About this record
Lead kit for deep brain stimulation is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000419_d8e90e711e6c46309bcb2be78628e33e_be9af1fb3fa80a2326121ab01c7fcd41. This device is marketed under the brand name Interstim. 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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