Implantable pacemaker with cardiac resynchronization therapy
- UID
- IMP/MD/2021/000379_e96cc9d3342543eaf273b8c3e3539af0_8e9a2eec5c57e76c6a99170448155ecb
- Device class
- Class D
- Brand name
- Cobalt™ XT DR MRI SureScan
- License holder
- India Medtronic Private Limited
- 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
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.
This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.