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_98fd4398af7b4d6efd8b4a6e9b12323e. 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_98fd4398af7b4d6efd8b4a6e9b12323e

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 (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 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

Cardiac Resynchronization therapy -Cardioverter/Defibrillator

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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

Implantable Cardioverter Defibrillator

Programmer Software

Programmer Software

Cardiac Resynchronization Therapy Defibrillator

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