Taiwan FDA registration 5ee22aae1372c887258fa8432c77a0bf

"Medtronic" wireless extracorporeal neurostimulator

TW: “美敦力”無線體外神經刺激器

Taiwan·Risk Class 3·Plexus Manufacturing Sdn. Bhd.;; Medtronic Inc.·Registered Apr 22, 2020 – Apr 22, 2030Active

Registration details

Analysis ID: 5ee22aae1372c887258fa8432c77a0bf
Customs Code: DHA05603340502

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: Contract manufacturing;; input

Dates and status

Registration Date: Apr 22, 2020
Expiry Date: Apr 22, 2030

About this record

Access comprehensive regulatory information for "Medtronic" wireless extracorporeal neurostimulator in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 5ee22aae1372c887258fa8432c77a0bf and manufactured by Plexus Manufacturing Sdn. Bhd.;; Medtronic Inc.. The authorized representative in Taiwan is MEDTRONIC (TAIWAN) LTD..

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