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CDSCO UID IMP/MD/2023/000505_0e05a5b37ad597a503bcd7b4d1dd2996_80181496a322bdb5182e48a4018f62e5

Cardiac Resynchronization Therapy Defibrillator

M/s St. Jude Medical India Pvt. Ltd·Device Class Class D·India CDSCO·Brand: Fortify Assura DR
Registration details
UID
IMP/MD/2023/000505_0e05a5b37ad597a503bcd7b4d1dd2996_80181496a322bdb5182e48a4018f62e5
Device class
Class D
Brand name
Fortify Assura DR
License holder
M/s St. Jude Medical India Pvt. Ltd
Approving authority
CDSCO
Product information
The Implantable Cardioverter Defibrillator (Fortify Assura DR) devices and Cardiac Resynchronization Therapy Defibrillator (Fortify Assura DR) 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 (Fortify Assura DR) due to VT (Fortify Assura DR) or VF (Fortify Assura DR). The device is most commonly implanted within a device pocket in the pectoral region. Cardiac Resynchronization Therapy (Fortify Assura DR) devices are indicated for reduction of symptoms in patients who have congestive heart failure, a reduced left ventricular ejection fraction (Fortify Assura DR) 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 (Fortify Assura DR) due to VT (Fortify Assura DR) or VF (Fortify Assura DR). The device is most commonly implanted within a device pocket in the pectoral region.
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About this record

Cardiac Resynchronization Therapy Defibrillator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000505_0e05a5b37ad597a503bcd7b4d1dd2996_80181496a322bdb5182e48a4018f62e5. This device is marketed under the brand name Fortify Assura DR. 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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