Defibrillation Leads - India CDSCO Medical Device Registration

Defibrillation Leads is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000222_af296841a958d451afc4bf9c34a6cf74_0638121e80e672d12e691759de4162fd. 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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CDSCO Registered

Class Class D

Defibrillation Leads

UID: IMP/MD/2021/000222_af296841a958d451afc4bf9c34a6cf74_0638121e80e672d12e691759de4162fd

Brand Name

Optisure

License Holder

M/s St. Jude Medical India Pvt. Ltd

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Optisure transvenous leads are indicated for use with compatible pulse generators . 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 configurations 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

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Defibrillation Leads

Brand: Optisure

M/s St. Jude Medical India Pvt. Ltd

Defibrillation Leads - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

Defibrillation Leads

Defibrillation Leads

Pulse generator

Pulse generator

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Implantable Cardioverter Defibrillator

Pacing Lead

Pacing Lead

Pacing Lead

DBS External Pulse Generator, 16 Channel

Percutaneous catheter

Catheter

Programmer

Implantable Cardioverter Defibrillator

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Programmer Software

Programmer Software

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