CDSCO UID IMP/MD/2023/000825_0e05a5b37ad597a503bcd7b4d1dd2996_e76b780cfcb700d9de3eb0e643d74ddc
Cardiac Resynchronization Therapy Defibrillator
M/s St. Jude Medical India Pvt. Ltd·Device Class Class D·India CDSCO·Brand: Merlin PCS 3650 Software
Registration details
- UID
- IMP/MD/2023/000825_0e05a5b37ad597a503bcd7b4d1dd2996_e76b780cfcb700d9de3eb0e643d74ddc
- Device class
- Class D
- Brand name
- Merlin PCS 3650 Software
- License holder
- M/s St. Jude Medical India Pvt. Ltd
- Approving authority
- CDSCO
- Product information
- The Implantable Cardioverter Defibrillator (Merlin PCS 3650 Software) devices and Cardiac Resynchronization Therapy Defibrillator (Merlin PCS 3650 Software) 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 (Merlin PCS 3650 Software) due to VT (Merlin PCS 3650 Software) or VF (Merlin PCS 3650 Software). The device is most commonly implanted within a device pocket in the pectoral region. Cardiac Resynchronization Therapy (Merlin PCS 3650 Software) devices are indicated for reduction of symptoms in patients who have congestive heart failure, a reduced left ventricular ejection fraction (Merlin PCS 3650 Software) 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 (Merlin PCS 3650 Software) due to VT (Merlin PCS 3650 Software) or VF (Merlin PCS 3650 Software). 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/2023/000825_0e05a5b37ad597a503bcd7b4d1dd2996_e76b780cfcb700d9de3eb0e643d74ddc. This device is marketed under the brand name Merlin PCS 3650 Software. 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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