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_53efb8cdd6fb98b5f394d4a572c61faa. 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_53efb8cdd6fb98b5f394d4a572c61faa

Brand Name

Cobalt™ XT DR MRI SureScan

License Holder

India Medtronic Private Limited

Device Class

Class D

Approving Authority

CDSCO

Product Information

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. Sensia DR 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