(MBX, MHY, NHL, PJS) -Master Percept and Activa Deep Brain Stimulation Therapy Systems

FDA premarket approval P960009/S361 · decided 2020-06-24

Approval details

PMA number

P960009

Supplement

S361

Supplement type

Normal 180 Day Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

(MBX, MHY, NHL, PJS) -Master Percept and Activa Deep Brain Stimulation Therapy Systems

Generic name

Stimulator, electrical, implanted, for parkinsonian tremor

Applicant

Medtronic, Inc.

Date received

2019-10-18

Decision date

2020-06-24

Days to decision

250 days

Decision code

APPR

Product code

MHY

Advisory committee

Neurology

Expedited review

No

Location

Minneapolis, MN

Statement

Approval for the following:1) Model B35200 Percept PC Implantable Neurostimulator (INS);2) Model B31060 Connector Plug;3) Updates to the Model A610 Clinician Programmer Application (PPA) Software to version 2.0;4) Updates to the Model A620 Patient Programmer Application (CPA) to version 2.0;5) Updates to the Model 8880T2 Communicator (clinician telemetry device) firmware; 6) New Model TH91 Handset and Communicator kit; and7) Labeling changes in physician and patient labeling for existing product

510(k) clearances by this applicant