Tiered-therapy Cardioverter/Defibrillator - India CDSCO Medical Device Registration

Tiered-therapy Cardioverter/Defibrillator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000767_4d70cdbc6b2e12f1ef084c2bc093a7a6_f6a93d8eb5996a83db1414e9edd57f1b. 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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CDSCO Registered

Class Class D

Tiered-therapy Cardioverter/Defibrillator

UID: IMP/MD/2021/000767_4d70cdbc6b2e12f1ef084c2bc093a7a6_f6a93d8eb5996a83db1414e9edd57f1b

Brand Name

Quadra Assura MP

License Holder

M/s St. Jude Medical India Pvt. Ltd

Device Class

Class D

Approving Authority

CDSCO

Product Information

St. Jude 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 (Quadra Assura MP) in those patients who remain symptomatic despite stable, optimal medical therapy (Quadra Assura MP) 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 (Quadra Assura MP) atrial fibrillation and have NYHA Class II or III heart failure