Deep Brain Stimulation (DBS)

FDA premarket approval P140009/S102 · decided 2024-08-08

Approval details

PMA number

P140009

Supplement

S102

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

Deep Brain Stimulation (DBS)

Generic name

Stimulator, electrical, implanted, for parkinsonian tremor

Applicant

ABBOTT MEDICAL

Date received

2024-07-08

Decision date

2024-08-08

Days to decision

31 days

Decision code

OK30

Product code

MHY

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