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CDSCO UID IMP/MD/2021/000767_8ea86474d70bba5a51d8f1e0d0a754c0_6d264c761f67a298e762f1ef5dfef91a

Implantable Cardioverter Defibrillator

M/s St. Jude Medical India Pvt. Ltd·Device Class Class D·India CDSCO·Brand: Quadra Assura MP
Registration details
UID
IMP/MD/2021/000767_8ea86474d70bba5a51d8f1e0d0a754c0_6d264c761f67a298e762f1ef5dfef91a
Device class
Class D
Brand name
Quadra Assura MP
License holder
M/s St. Jude Medical India Pvt. Ltd
Approving authority
CDSCO
Product information
The Implantable Cardioverter Defibrillator (Quadra Assura MP) devices and Cardiac Resynchronization Therapy Defibrillator (Quadra Assura MP) devices are primarily intended for use with compatible leads to detect and treat life threatening ventricular arrythmias by providing ventricular antitachycardia pacing, and ventricular cardioversion/ defibrillation. In addition, these devices can detect and treat chronic symptomatic bradyarrhythmia by providing sensing and pacing in the right ventricle, and various atrioventricular conduction abnormalities by providing sensing and pacing in the right ventricle and/or the right atrium. CRT-D devices sense cardiac activity and provide pacing to resynchronize the right and left ventricles. ICD devices are indicated in patients who have already survived a cardiac arrest or are at a high risk of Sudden Cardiac Death (Quadra Assura MP) due to VT (Quadra Assura MP) or VF (Quadra Assura MP). The device is most commonly implanted within a device pocket in the pectoral region. Cardiac Resynchronization Therapy (Quadra Assura MP) devices are indicated for reduction of symptoms in patients who have congestive heart failure, a reduced left ventricular ejection fraction (Quadra Assura MP) and a prolonged QRS duration. CRT-D devices are indicated in patients who meet the CRT indications and have already survived a cardiac arrest or are at a high risk of Sudden Cardiac Death (Quadra Assura MP) due to VT (Quadra Assura MP) or VF (Quadra Assura MP). The device is most commonly implanted within a device pocket in the pectoral region
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About this record

Implantable Cardioverter Defibrillator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000767_8ea86474d70bba5a51d8f1e0d0a754c0_6d264c761f67a298e762f1ef5dfef91a. This device is marketed under the brand name Quadra Assura MP. The license holder is M/s St. Jude Medical India Pvt. Ltd, and it is classified as Device Class Class D. The approving authority is CDSCO.

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