Taiwan FDA registration f25ed02f9196dc9d1a661c635a42609f

"Medtronic" neuromodulation system controller and charger

TW: “美敦力”神經調控系統控制器及充電器

Taiwan·Risk Class 3·Plexus Manufacturing Sdn. Bhd.;; Medtronic Inc.·Registered Apr 29, 2020 – Apr 29, 2030Active

Registration details

Analysis ID: f25ed02f9196dc9d1a661c635a42609f
Customs Code: DHA05603340601

Company information

Manufacturer: Plexus Manufacturing Sdn. Bhd.;; Medtronic Inc.
Manufacturer Country: United States;;Malaysia
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: Input;; Contract manufacturing

Dates and status

Registration Date: Apr 29, 2020
Expiry Date: Apr 29, 2030

About this record

Access comprehensive regulatory information for "Medtronic" neuromodulation system controller and charger in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number f25ed02f9196dc9d1a661c635a42609f and manufactured by Plexus Manufacturing Sdn. Bhd.;; Medtronic Inc.. The authorized representative in Taiwan is MEDTRONIC (TAIWAN) LTD..

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