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Singapore HSA registration DE0500651

Medtronic Specify SureScan MRI Surgical Lead Kits

Singapore flagSingapore·CLASS D·Medtronic, Inc.·Registered September 14, 2017
Device classification
Device Class
CLASS D
Medical Speciality Area
Neurology
Registration information
Registration Number
DE0500651
Registration Date
September 14, 2017
Change Notification Approval Date
July 26, 2024
Retention Due Date
September 13, 2025
Product description
The Medtronic Spinal Cord Stimulation (SCS) neurostimulation system is indicated for SCS as an aid in the management of chronic, intractable pain of the trunk and/or limbs associated with: ▪ Failed Back Surgery Syndrome ▪ Chronic back and/or radicular limb pain ▪ Complex Regional Pain Syndromes ▪ Diabetic Peripheral Neuropathy.
Product Owner
Name
Medtronic, Inc.
Short Name
Medtronic, Inc.
Address
710 Medtronic Parkway,, Minneapolis, MN 55432-5604, UNITED STATES
Registrant
Name
MEDTRONIC INTERNATIONAL, LTD.
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
Name
MEDTRONIC INTERNATIONAL TRADING PTE. LTD. MEDTRONIC INTERNATIONAL, LTD.
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model information
Model Name(s)
Specify® SureScan® MRI 5-6-5 Specify® SureScan® MRI 5-6-5 Specify® SureScan® MRI 2x8 Specify® SureScan® MRI 2x8
Model Identifier(s)
977C165 977C190 977C265 977C290
About this record

Access comprehensive regulatory information for Medtronic Specify SureScan MRI Surgical Lead Kits in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0500651 and owned by Medtronic, Inc.. The device was registered on September 14, 2017.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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