Eterna SCS System

FDA premarket approval P010032/S200 · decided 2023-10-05

Approval details

PMA number

P010032

Supplement

S200

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

Eterna SCS System

Generic name

Stimulator, spinal-cord, totally implanted for pain relief

Applicant

ABBOTT MEDICAL

Date received

2023-07-07

Decision date

2023-10-05

Days to decision

90 days

Decision code

APPR

Product code

LGW

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

Approval for software update (from 1.0 to 1.1) of the CP and PC Apps. These apps are used by the clinician and patient, respectively, to program or control the Eterna SCS neurostimulation system. The proposed minor design change will update the CP and PC software to address the incorrect formula assumption and display a battery message after the device is past the current lifetime as defined in the product requirement. This change is being made to address field complaints regarding the PC genera

510(k) clearances by this applicant