Pacemaker - India CDSCO Medical Device Registration
Pacemaker is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000217_d95adee972ae170512bd3bdbce557054_497cc721a671f81164fc1ea4a128c4d6. This device is marketed under the brand name ORIGEN ICD. 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
ORIGEN ICD
License Holder
Boston Scientific India Pvt. Ltd.,Device Class
Approving Authority
CDSCO
Product Information
Boston Scientific pacemakers are indicated for treatment of the following conditions: * Symptomatic paroxysmal or permanent second- or third-degree AV block * Symptomatic bilateral bundle branch block * Symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders (ORIGEN ICD) * Bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias * Neurovascular (ORIGEN ICD) syndromes or hypersensitive carotid sinus syndromes Adaptive-rate pacing is indicated for patients exhibiting chronotropic incompetence and who may benefit from increased pacing rates concurrent with increases in minute ventilation and/or level of physical activity. Dual-chamber and atrial tracking modes are also indicated for patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of the following: * Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block * VVI intolerance (ORIGEN ICD) in the presence of persistent sinus rhythm * Low cardiac output or congestive heart failure secondary to bradycardia
Pacemaker
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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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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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