Infinity™ Deep Brain Stimulation (DBS)

FDA premarket approval P140009/S109 · decided 2025-01-13

Approval details

PMA number

P140009

Supplement

S109

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

Infinity™ Deep Brain Stimulation (DBS)

Generic name

Stimulator, electrical, implanted, for parkinsonian tremor

Applicant

ABBOTT MEDICAL

Date received

2024-10-15

Decision date

2025-01-13

Days to decision

90 days

Decision code

APPR

Product code

MHY

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

Approval for firmware version 1.3 and OneApp version 4.1, which include an expanded impedance range and updated trim values used for Magnetic Resonance Imaging (MRI) Mode, updated Elective Replacement Indicator requirement for Orion IPG systems, and labeling updates to account for these changes. You are also proposing to add a check for the MR conditional status of the combination of leads and Implanted Pulse Generators before entering MRI Mode, specify spinal cord stimulation therapy type for t

510(k) clearances by this applicant