Defibrillation Leads
- UID
- IMP/MD/2021/000222_af296841a958d451afc4bf9c34a6cf74_e768d5c815b4ddcc72612ee2ae5b5789
- Device class
- Class D
- Brand name
- Optisure
- License holder
- M/s St. Jude Medical India Pvt. Ltd
- Approving authority
- CDSCO
- Product information
- The Durata transvenous leads are indicated for use with compatible pulse generator (Optisure). They provide pacing and sensing and deliver cardioversion/defibrillation therapy to the heart. A Transvenous lead system may offer the patient the benefit of avoiding a thoracotomy for lead implantation. If the initial lead configuration is not effective, repositioning of the lead or other lead configuration should be attempted. In some patients, a nonthoracotomy lead configuration may not provide reliable conversion of arrhythmias, and the use of subcutaneous or epicardial patch defibrillation leads should be considered
Defibrillation Leads is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000222_af296841a958d451afc4bf9c34a6cf74_e768d5c815b4ddcc72612ee2ae5b5789. This device is marketed under the brand name Optisure. The license holder is M/s St. Jude Medical India Pvt. Ltd, and it is classified as Device Class Class D. The approving authority is CDSCO.
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