Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)

FDA premarket approval P140009/S063 · decided 2020-08-18

Approval details

PMA number

P140009

Supplement

S063

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)

Generic name

Stimulator, electrical, implanted, for parkinsonian tremor

Applicant

ABBOTT MEDICAL

Date received

2020-07-27

Decision date

2020-08-18

Days to decision

22 days

Decision code

APPR

Product code

MHY

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

Approval for a minor design change to remove a microelectromechanical systems (MEMS) sensor, which is an accelerometer component on the IPG’s printed circuit board. This MEMS sensor was intended to detect and collect data on patient activity levels for research and development purposes only; it is not related to product performance.

510(k) clearances by this applicant