CDSCO UID IMP/MD/2018/000406_4d70cdbc6b2e12f1ef084c2bc093a7a6_faf46f5df0f3046861ccf14a6b3e6301

Tiered-therapy Cardioverter/Defibrillator

M/s St. Jude Medical India Pvt. Ltd·Device Class Class D·India CDSCO·Brand: CPS Aim™ SL
Registration details
UID
IMP/MD/2018/000406_4d70cdbc6b2e12f1ef084c2bc093a7a6_faf46f5df0f3046861ccf14a6b3e6301
Device class
Class D
Brand name
CPS Aim™ SL
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 (CPS Aim™ SL) 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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About this record

Tiered-therapy Cardioverter/Defibrillator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000406_4d70cdbc6b2e12f1ef084c2bc093a7a6_faf46f5df0f3046861ccf14a6b3e6301. This device is marketed under the brand name CPS Aim™ SL. 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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