Tiered-therapy Cardioverter/Defibrillator
- UID
- IMP/MD/2021/000767_4d70cdbc6b2e12f1ef084c2bc093a7a6_f6a93d8eb5996a83db1414e9edd57f1b
- Device class
- Class D
- Brand name
- Quadra Assura MP
- License holder
- M/s St. Jude Medical India Pvt. Ltd
- 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
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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