Deep Brain Stimulation (DBS) Neurostimulation System

FDA premarket approval P140009/S124 · decided 2025-11-07

Approval details

PMA number

P140009

Supplement

S124

Supplement type

Normal 180 Day Track

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

Deep Brain Stimulation (DBS) Neurostimulation System

Generic name

Stimulator, electrical, implanted, for parkinsonian tremor

Applicant

ABBOTT MEDICAL

Date received

2025-08-11

Decision date

2025-11-07

Days to decision

88 days

Decision code

APPR

Product code

MHY

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

for following changes related to the Patient Magnet, which is an external medical device accessory. 1) Design Modifications: Magnet shape, Magnet Enclosure, Foam, Keeper covers and Keeper sheet (from stainless steel coated with epoxy to carbon steel)2) Material Update: Raw Magnet material change from Alloy of Aluminum-Nickel-Cobalt to Neodymium; Addition of Magnet Enclosures and Keeper covers made of Sabic Cycoloy HC1204HF, Polycarbonate (PC) and Acrylonitrile-butadiene-styrene (ABS) blend. 3) S

510(k) clearances by this applicant