Eterna SCS IPG, Charger, Patient Controller Application, Clinician Programmer Application

FDA premarket approval P010032/S186 · decided 2022-12-16

Approval details

PMA number

P010032

Supplement

S186

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

Eterna SCS IPG, Charger, Patient Controller Application, Clinician Programmer Application

Generic name

Stimulator, spinal-cord, totally implanted for pain relief

Applicant

ABBOTT MEDICAL

Date received

2022-04-01

Decision date

2022-12-16

Days to decision

259 days

Decision code

APPR

Product code

LGW

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

Approval for approval for commercial distribution of Abbotts Eterna Spinal Cord Stimulation (SCS) System. This system consists of a rechargeable Implantable Pulse Generator (IPG), Charging System, and Clinician Programmer Application and Patient Controller Application. These components are intended to be used with commercially available SCS leads, extensions and accessories.

510(k) clearances by this applicant