Implantable Neurostimulator - India CDSCO Medical Device Registration

Implantable Neurostimulator is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000040_3930b1d5a7d2098f6c551236decc44b0_bf6e30e63678d3fb062264ea73c423ac. This device is marketed under the brand name Ascenda. 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

Implantable Neurostimulator

UID: IMP/MD/2019/000040_3930b1d5a7d2098f6c551236decc44b0_bf6e30e63678d3fb062264ea73c423ac

Brand Name

Ascenda

License Holder

India Medtronic Private Limited

Device Class

Class D

Approving Authority

CDSCO

Product Information

Neurostimulation for spinal cord stimulation (Ascenda) - The Medtronic SCS neurostimulation system is indicated for SCS as an aid in the management of the following conditions: ▪ chronic, intractable pain of the trunk and/or limbs. ▪ stable intractable Angina Pectoris in patients who are not candidates for revascularization. * ▪ stable intractable Peripheral Vascular Disease of Fontaine Stage II or higher in patients who are not candidates for revascularization. ** Physicians using SCS to treat these conditions are encouraged to share their results in scientific exchange or with Medtronic. Neurostimulation for Peripheral Nerve Stimulation (Ascenda) using percutaneous leads - A Medtronic PNS neurostimulation system is indicated for PNS as an aid in the management of chronic, intractable pain of the posterior trunk. Neurostimulation for Peripheral Nerve Stimulation (Ascenda) using surgical leads – A Medtronic PNS neurostimulation system is indicated for PNS as an aid in the management of chronic, intractable pain of the trunk and/or limbs