Spinal Cord Stimulation (SCS)

FDA premarket approval P010032/S221 · decided 2024-08-08

Approval details

PMA number

P010032

Supplement

S221

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

Spinal Cord Stimulation (SCS)

Generic name

Stimulator, spinal-cord, totally implanted for pain relief

Applicant

ABBOTT MEDICAL

Date received

2024-07-08

Decision date

2024-08-08

Days to decision

31 days

Decision code

OK30

Product code

LGW

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

supplier-related changes, including 1) an additional raw material supplier of Grade 2 Titanium; and 2) changing the primary dimensional inspection method from the optical gaging product measurement method to the laser inspection method, for the feedthru component within the Eterna Spinal Cord Stimulation Implantable Pulse Generator and Liberta RC Deep Brain Stimulation Implantable Pulse Generator

510(k) clearances by this applicant