Taiwan FDA registration 5ad065cdd403fd51cbec16741fd4fb7b

"Medtronic" Sbeth magnetic resonance electrode lead set

TW: “美敦力”史貝斯磁振造影電極導線套組

Taiwan·Risk Class 3·Medtronic Inc.;; MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA·Registered May 07, 2020 – May 07, 2025Expired

Registration details

Analysis ID: 5ad065cdd403fd51cbec16741fd4fb7b
Customs Code: DHA05603340907

Company information

Manufacturer: Medtronic Inc.;; MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
Manufacturer Country: United States
Authorized Representative: MEDTRONIC (TAIWAN) LTD.

Product details

Intended Use: The Intellis SCS Neurostimulation System is suitable for the following conditions to assist in the management of: ̇Chronic intractable pain in the trunk and/or extremities. ̇Patients with stable intractable angina who are ineffective or unsuitable for revascularization after medical treatment or revascularization. ̇Patients with stable refractory peripheral vascular disease classified as stage 2 or above and not suitable for revascularization.
Product Type (Level 1): K Neuroscience
Product Type (Level 2): K.5880 Implantable spinal cord stimulator for pain relief
Import Information: import

Dates and status

Registration Date: May 07, 2020
Expiry Date: May 07, 2025

About this record

Access comprehensive regulatory information for "Medtronic" Sbeth magnetic resonance electrode lead set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 5ad065cdd403fd51cbec16741fd4fb7b and manufactured by Medtronic Inc.;; MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA. The authorized representative in Taiwan is MEDTRONIC (TAIWAN) LTD..

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