Implantable Cardioverter Defibrillator - India CDSCO Medical Device Registration

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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CDSCO Registered

Class Class D

Implantable Cardioverter Defibrillator

UID: IMP/MD/2021/000201_8ea86474d70bba5a51d8f1e0d0a754c0_b4328a29d27eb8b566f4265ba1ae790c

Brand Name

Endurity Core

License Holder

M/s St. Jude Medical India Pvt. Ltd

Device Class

Class D

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

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Implantable Cardioverter Defibrillator

Brand: Merlin PCS 3650 Software

M/s St. Jude Medical India Pvt. Ltd

Implantable Cardioverter Defibrillator - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

Implantable Cardioverter Defibrillator

Implantable Cardioverter Defibrillator

Implantable Cardioverter Defibrillator

Implantable Cardioverter Defibrillator

Implantable Cardioverter Defibrillator

Implantable Cardioverter Defibrillator

Implantable Cardioverter Defibrillator

Implantable Cardioverter Defibrillator

Implantable Cardioverter Defibrillator

Implantable Cardioverter Defibrillator

DBS External Pulse Generator, 16 Channel

Percutaneous catheter

Catheter

Programmer

Implantable Cardioverter Defibrillator

Implantable Cardioverter Defibrillator

Programmer Software

Programmer Software

Cardiac Resynchronization Therapy Defibrillator

Cautery Unit