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Abbott Medical Eterna Implantable Pulse Generator - HSA Registration DE0510694

Access comprehensive regulatory information for Abbott Medical Eterna Implantable Pulse Generator in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0510694 and owned by Abbott Medical. The device was registered on May 07, 2025.

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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CLASS D
DE0510694
Abbott Medical Eterna Implantable Pulse Generator
HSA Registration Number: DE0510694
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Product Description

This neurostimulation system is designed to deliver lowโ€‘intensity electrical impulses to nerve structures. The system is intended to be used with leads, associated extensions, and accessories that are compatible with the system. This neurostimulation system is indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome and intractable low back and leg pain.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Neurology
Registration Information
Registration Number
DE0510694
Registration Date
May 07, 2025
Retention Due Date
May 06, 2026
Product Owner
Short Name
Abbott Medical
Address
6901 Preston Road, Plano, Texas 75024, UNITED STATES
Registrant
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352 262 BALESTIER ROAD, OKIO, #03-03, SINGAPORE 329714
Model Information
Model Name(s)
Torque Wrench Epidural Needle, 14 gauge Epidural Needle, 14 gauge Swift-Lock Anchor Cinch Lead Anchor Patient Magnet Adhesive Pouch, EPG Nonadhesive Pouch with Belt, EPG Port Plug Charger Lumbar Charging Apparel Pectoral Charging Apparel 8CH Adapter, M 8CH Adapter, M Multilead Trial Cable SCS EPG, 2 Port Header Octrode Trial Lead Kit Octrode Lead Kit Octrode Lead Kit Penta 3mm Lead Eterna Implantable Pulse Generator Lamitrode 88 Lead Kit TriCentrus 16 Lead Extension Extension SCS EPG, 16 Channel Charger Kit, Lumbar Clinician Programmer Patient Controller Patient Controller Clinician Programmer
Model Identifier(s)
1101 1114 1116 1192 1194 1210 1213 1214 12710 16000 16750 16760 2311 2316 3013 3032 3086 3186 3189 3228 32400 3288 3292 3383 3386 3599 36000 3874 3875 55500 55600