St. Jude Medical Infinity DBS Implantable Pulse Generator

FDA premarket approval P140009/S039 · decided 2020-01-02

Approval details

PMA number

P140009

Supplement

S039

Supplement type

Panel Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

St. Jude Medical Infinity DBS Implantable Pulse Generator

Generic name

Stimulator, electrical, implanted, for parkinsonian tremor

Applicant

ABBOTT MEDICAL

Date received

2018-07-11

Decision date

2020-01-02

Days to decision

540 days

Decision code

APPR

Product code

MHY

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

Approval for expanding the indications to include bilateral stimulation of the internal globus pallidus (GPi) as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive Parkinsons disease that is not adequately controlled by medications.. This device is indicated for:1) Bilateral stimulation of the subthalamic nucleus (STN) or the internal GPi as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive Parkinsons disease that is not adequa

510(k) clearances by this applicant