Implantable pacemaker with cardiac resynchronization therapy - India CDSCO Medical Device Registration

Implantable pacemaker with cardiac resynchronization therapy is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000379_e96cc9d3342543eaf273b8c3e3539af0_8e9a2eec5c57e76c6a99170448155ecb. 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

Implantable pacemaker with cardiac resynchronization therapy

UID: IMP/MD/2021/000379_e96cc9d3342543eaf273b8c3e3539af0_8e9a2eec5c57e76c6a99170448155ecb

Brand Name

Cobalt™ XT DR MRI SureScan

License Holder

India Medtronic Private Limited

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Consulta CRT-P system is indicated for any of the following types of heart failure patients: ● Patients with ventricular dyssynchrony ● Patients with reduced ejection fraction (Cobalt™ XT DR MRI SureScan ), regardless of New York Heart Association (Cobalt™ XT DR MRI SureScan ) class, who are indicated for ventricular pacing, and have high degree AV block ● Patients with reduced EF and all of the following characteristics: – Have received a conventional pacemaker or ICD – Have subsequently developed worsening HF despite optimal medical therapy – Have a high proportion of RV pacing Rate adaptive pacing is provided for patients who may benefit from increased pacing rates concurrent with increases in activity. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony

Class D

Implantable Cardioverter Defibrillator

Brand: Cobalt™ XT DR MRI SureScan

India Medtronic Private Limited

Class D

Class C