Impantable Pulse Generator - India CDSCO Medical Device Registration
Impantable Pulse Generator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000301_3a8b0e262192a9e5e28e36504f6456cf_ab6c4c0fcab44188f8b1f090f5b6d1e9. This device is marketed under the brand name Vercise PC Impantable Pulse Generator Kit. The license holder is Boston Scientific India Pvt. Ltd.,, and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
Vercise PC Impantable Pulse Generator Kit
License Holder
Boston Scientific India Pvt. Ltd.,Device Class
Approving Authority
CDSCO
Product Information
The Vercise Gevia DBS System is indicated for use in the following: • Unilateral or bilateral stimulation of the subthalamic nucleus (Vercise PC Impantable Pulse Generator Kit) or internal globus pallidus (Vercise PC Impantable Pulse Generator Kit) for levodopa-responsive Parkinson’s disease which is not adequately controlled with medication. • Unilateral or bilateral stimulation of the subthalamic nucleus (Vercise PC Impantable Pulse Generator Kit) or internal globus pallidus (Vercise PC Impantable Pulse Generator Kit) for intractable primary and secondary dystonia, for persons 7 years of age and older. • Thalamic stimulation for the suppression of tremor not adequately controlled by medications in patients diagnosed with Essential Tremor or Parkinson’s disease.
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