Implantable Cardioverter Defibrillator
- UID
- IMP/MD/2021/000201_8ea86474d70bba5a51d8f1e0d0a754c0_b4328a29d27eb8b566f4265ba1ae790c
- Device class
- Class D
- Brand name
- Endurity Core
- License holder
- M/s St. Jude Medical India Pvt. Ltd
- Approving authority
- CDSCO
- Product information
- The devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Cardiac Resynchronization Therapy devices (Endurity Core) are also intended to resynchronize the right and left ventricles in patients with congestive heart failure. AT/AF Detection Algorithm. The AT/AF detection algorithm is indicated for detecting atrial tachyarrhythmias which have been found to be associated with an increased risk of stroke in elderly, hypertensive, pacemaker patients without prior history of AF
Implantable Cardioverter Defibrillator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000201_8ea86474d70bba5a51d8f1e0d0a754c0_b4328a29d27eb8b566f4265ba1ae790c. This device is marketed under the brand name Endurity Core. 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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