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/2021/000379_d95adee972ae170512bd3bdbce557054_dd47bcfd9f6fed6ab4b6ba34e330f8fd. This device is marketed under the brand name Cobalt™ XT DR MRI SureScan . The license holder is India Medtronic Private Limited, 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/2021/000379_d95adee972ae170512bd3bdbce557054_dd47bcfd9f6fed6ab4b6ba34e330f8fd

Brand Name

Cobalt™ XT DR MRI SureScan

License Holder

India Medtronic Private Limited

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Ensura MRI SureScan system is indicated to restore physiologic heart rates, improve cardiac output, prevent symptoms, or protect against arrhythmias related to cardiac impulse formation or conduction disorders. The device is indicated for use in patients who may benefit from rate-responsive pacing to support cardiac output during varying levels of activity

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Pacemaker

Brand: Vitatron

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

Class D