Implantable Pacemaker - India CDSCO Medical Device Registration

Implantable Pacemaker is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000402_9f31c47bc4a6a380091006ed1ae50afd_1ab83a33c2adbdc8098a51401b4a1986. This device is marketed under the brand name Enticos. The license holder is Biotronik Medical Devices 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

Implantable Pacemaker

UID: IMP/MD/2021/000402_9f31c47bc4a6a380091006ed1ae50afd_1ab83a33c2adbdc8098a51401b4a1986

Brand Name

Enticos

License Holder

Biotronik Medical Devices India Pvt Ltd.

Device Class

Class D

Approving Authority

CDSCO

Product Information

Enitra is an implantable pacemaker that can be implanted for all bradycardia arrhythmia indications. The primary objective of the therapy consists of improving patients' symptoms that can be clinically manifested. The implantation of the pacemaker is a symptomatic therapy with the following objective: •Compensation of bradycardia by atrial, ventricular, or AV sequential pacing •Additional triple-chamber features: Resynchronization of ventricular chamber contraction via biventricular pacing

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IMPLANTABLE, STEROID ELUTING, MR CONDITIONAL CORONARY SINUS LEADS

Brand: Enticos

Biotronik Medical Devices India Pvt Ltd.

Implantable Pacemaker - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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IMPLANTABLE, STEROID ELUTING, MR CONDITIONAL CORONARY SINUS LEADS

Implantable Pacemaker

Implantable Pacemaker

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IMPLANTABLE, STEROID ELUTING, MR CONDITIONAL CORONARY SINUS LEADS

Implantable Pacemaker

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