Cardiac Resynchronization therapy -Cardioverter/Defibrillator - India CDSCO Medical Device Registration

Cardiac Resynchronization therapy -Cardioverter/Defibrillator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000222_96b147b9a6501ec59e177e305240b65a_a8bdc2ebd8050f8c4affcbcc2899e75e. This device is marketed under the brand name Optisure. 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

Cardiac Resynchronization therapy -Cardioverter/Defibrillator

UID: IMP/MD/2021/000222_96b147b9a6501ec59e177e305240b65a_a8bdc2ebd8050f8c4affcbcc2899e75e

Brand Name

Optisure

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 (Optisure) 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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Defibrillation Leads

Brand: Optisure

M/s St. Jude Medical India Pvt. Ltd

Cardiac Resynchronization therapy -Cardioverter/Defibrillator - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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Defibrillation Leads

Defibrillation Leads

Defibrillation Leads

Pulse generator

Pulse generator

Implantable Cardioverter Defibrillator

Implantable Cardioverter Defibrillator

Pacing Lead

Pacing Lead

Pacing Lead

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