Activa Deep Brain Stimulation Therapy System

FDA premarket approval P960009/S297 · decided 2017-10-20

Approval details

PMA number

P960009

Supplement

S297

Supplement type

Special (Immediate Track)

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

Activa Deep Brain Stimulation Therapy System

Generic name

Stimulator, electrical, implanted, for parkinsonian tremor

Applicant

Medtronic, Inc.

Date received

2017-09-20

Decision date

2017-10-20

Days to decision

30 days

Decision code

APPR

Product code

MHY

Advisory committee

Neurology

Expedited review

No

Location

Minneapolis, MN

Statement

Approval for the addition of new safety information (tunneling procedure unintended nerve tissue injury warning and adverse event, loss of coordination precaution, weight gain/loss adverse event) and safety enhancement clarifications (update guidance on avoiding damage to the neurostimulator (Physician Labeling), clarify text that accompanies the figure for accurate right and left hemisphere lead-extension connection when placing dual lead systems (Physician Labeling), remove incorrect length of

510(k) clearances by this applicant