Pacemaker - India CDSCO Medical Device Registration

Pacemaker is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000553_d95adee972ae170512bd3bdbce557054_61d4364a01bc079dd0a1b46c40321e85. This device is marketed under the brand name Vitatron. The license holder is India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Pacemaker

UID: IMP/MD/2021/000553_d95adee972ae170512bd3bdbce557054_61d4364a01bc079dd0a1b46c40321e85

Brand Name

Vitatron

License Holder

India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India

Device Class

Class D

Approving Authority

CDSCO

Product Information

Pacemakers are intended for long-term use to monitor and regulate the patient’s heart rate. Pacemakers sense intrinsic electrical activity through lead electrodes, analyze heart rhythms based on programmed detection parameters, and deliver pacing pulses to treat bradyarrhythmias. The software is intended to provide information which is used to make decisions with diagnostic or therapeutic devices

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