Delivery catheter - India CDSCO Medical Device Registration

Delivery catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000050_49528ccf5b9f40cd5ec63e39a313cc06_3b4f3fcf6179efbcc255fac067994477. This device is marketed under the brand name Onyx TruCor Zotarolimus-Eluting Coronary Stent System. 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

Delivery catheter

UID: IMP/MD/2019/000050_49528ccf5b9f40cd5ec63e39a313cc06_3b4f3fcf6179efbcc255fac067994477

Brand Name

Onyx TruCor Zotarolimus-Eluting Coronary Stent System

License Holder

India Medtronic Private Limited

Device Class

Class D

Approving Authority

CDSCO

Product Information

Micra Model MC1VR01 is indicated for use in patients who have experienced one or more of the following conditions: · paroxysmal or permanent high-grade AV block in the presence of AF · paroxysmal or permanent high-grade AV block in the absence of AF, as an alternative to dual chamber pacing, when a dual chamber transvenous pacing system is considered difficult, high risk, or not deemed necessary for effective therapy · symptomatic bradycardia-tachycardia syndrome or sinus node dysfunction (Onyx TruCor Zotarolimus-Eluting Coronary Stent System), as an alternative to atrial or dual chamber pacing, when a dual-chamber transvenous pacing system is considered difficult, high risk, or not deemed necessary for effective therapy Rate-responsive pacing is indicated to provide increased heart rate appropriate to increasing levels of activity. The device is designed to be used only in the right ventricle