Lead Extension kit - India CDSCO Medical Device Registration
Lead Extension kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000648_2704adc671a2b0d60609942d47f02054_ed2649bf91ffaec1793ff37d44e87df8. This device is marketed under the brand name 2x8 Contact Lead Extension 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
2x8 Contact Lead Extension kit
License Holder
Boston Scientific India Pvt. Ltd.,Device Class
Approving Authority
CDSCO
Product Information
The Vercise Deep Brain Stimulation System is indicated for use in the following: • Unilateral or bilateral stimulation of the subthalamic nucleus (2x8 Contact Lead Extension kit) or internal globus pallidus (2x8 Contact Lead Extension kit) for levodopa‑responsive Parkinson’s disease that is not adequately controlled with medication. • Unilateral or bilateral stimulation of the subthalamic nucleus (2x8 Contact Lead Extension kit) or internal globus pallidus (2x8 Contact Lead Extension kit) for treatment of intractable primary and secondary dystonia, for persons 7 years of age and older. • Thalamic stimulation for the suppression of tremor that is not adequately controlled by medications in patients diagnosed with Essential Tremor or Parkinson’s disease.
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