Infinity Deep Brain Stimulation (DBS) System

FDA premarket approval P140009/S050 · decided 2019-09-05

Approval details

PMA number

P140009

Supplement

S050

Supplement type

Special (Immediate Track)

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

Infinity Deep Brain Stimulation (DBS) System

Generic name

Stimulator, electrical, implanted, for parkinsonian tremor

Applicant

ABBOTT MEDICAL

Date received

2019-08-09

Decision date

2019-09-05

Days to decision

27 days

Decision code

APPR

Product code

MHY

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

Approval of the Changes Being Effected (CBE) for the Infinity Deep Brain Stimulation System. The changes being effected include: 1) Changes to DBS System physician and patient labeling, to enhance and harmonize the information regarding the risks of depression, suicide ideation, and suicide across the device type; and2) A minor change to the Program Storage Capacity Section of the Infinity IPG Clinicians Manual to updated from 15 programs with 1 stim set per lead to 15 programs to reflect the ad

510(k) clearances by this applicant