Lead and Extension Insertion tool - India CDSCO Medical Device Registration

Lead and Extension Insertion tool is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000339_7ca12fcf20c3d2f7403c6f7ec3f11db4_33f0a5e0b6525a94ed5b222f7186fd67. This device is marketed under the brand name Brio™ Patient Controller . The license holder is M/s St. Jude Medical India Pvt. Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Lead and Extension Insertion tool

UID: IMP/MD/2021/000339_7ca12fcf20c3d2f7403c6f7ec3f11db4_33f0a5e0b6525a94ed5b222f7186fd67

Brand Name

Brio™ Patient Controller

License Holder

M/s St. Jude Medical India Pvt. Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

The St. Jude Medical™ lead and extension insertion tool is a hand-manipulated device that is intended for a single use to help insert the terminal end of a neurostimulation lead, extension, or adapter into the header of an implantable pulse generator (Brio™ Patient Controller ) during implantation of a neurostimulation system