Pacing Lead - India CDSCO Medical Device Registration

Pacing Lead is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000222_7ced2c3ea8dce3d130cf57913ed1ed17_62970da83d21bb5ea8875c72835cdbdb. 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

Pacing Lead

UID: IMP/MD/2021/000222_7ced2c3ea8dce3d130cf57913ed1ed17_62970da83d21bb5ea8875c72835cdbdb

Brand Name

Optisure

License Holder

M/s St. Jude Medical India Pvt. Ltd

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Tendril STS Model 2088TC lead is designed for permanent sensing and pacing in either the right atrium or the right ventricle, in combination with a compatible device. Active leads such as Tendril STS Model 2088TC leads may be indicated for patients where permanent fixation of passive leads is suspected to be unstable. In atrial applications, the use of a screw-in lead such as Tendril STS Model 2088TC leads may be indicated in the presence of an abnormal, surgically altered or excised atrial appendage

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Defibrillation Leads

Brand: Optisure

M/s St. Jude Medical India Pvt. Ltd

Pacing Lead - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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