HSA · registration DE0510694Abbott Medical Eterna Implantable Pulse Generator
- Registration number
- DE0510694
- Model name
- 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
- 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
- Registration date
- May 07, 2025
- Risk class
- Class D
- Product owner
- Abbott Medical
- Registrant / registration holder
- ABBOTT MEDICAL (SINGAPORE), PTE. LTD.
This neurostimulation system is designed to deliver low‑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.
- Product owner address
- 6901 Preston Road, Plano, Texas 75024, United States
- Registrant address
- 3 FRASER STREET, #23-28, DUO TOWER, Singapore 189352
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.