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_a750ab477d4c2f8f03d5fb05f7a2db79. 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_a750ab477d4c2f8f03d5fb05f7a2db79

Brand Name

Cobalt™ XT DR MRI SureScan

License Holder

India Medtronic Private Limited

Device Class

Class D

Approving Authority

CDSCO

Product Information

Medtronic Relia Series implantable pulse generators (Cobalt™ XT DR MRI SureScan ) are indicated for use to improve cardiac output, prevent symptoms, or protect against arrhythmias related to cardiac impulse formation or conduction disorders. These devices are indicated for use in patients who are experiencing exercise intolerance or exercise restrictions related to an arrhythmia. Using rate response modes may restore heart rate variability and improve cardiac output. Relia SR Series implantable pulse generators are indicated for single use only

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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