Cardiac Resynchronization Therapy Defibrillator - India CDSCO Medical Device Registration
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_1a95e7361ff6e0aff4bbdc2947ff1a3b. 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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Brand Name
Fortify Assura DR
License Holder
M/s St. Jude Medical India Pvt. LtdDevice Class
Approving Authority
CDSCO
Product Information
Abbott Medical ICDs and CRT‑Ds are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. AF Suppression™ pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indication and sinus node dysfunction. In patients indicated for an ICD, CRT‑Ds are also intended: ▪ to provide a reduction of the symptoms of moderate to severe heart failure (Fortify Assura DR) in those patients who remain symptomatic despite stable, optimal medical therapy (Fortify Assura DR) and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration ▪ to maintain synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic (Fortify Assura DR) atrial fibrillation and have NYHA Class II or III heart failure
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