PMA P960009S361

Device: (MBX, MHY, NHL, PJS) -Master Percept and Activa Deep Brain Stimulation Therapy Systems
Applicant: Medtronic, Inc.
Product code: MHY
Decision date: 2020-06-24
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Approval order 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 products, to be consistent with the proposed labeling for the new Percept PC System.

Current openFDA PMA Record#

Device: (MBX, MHY, NHL, PJS) -Master Percept and Activa Deep Brain Stimulation Therapy Systems
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S361
Product code: MHY
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Decision date: 2020-06-24
Decision code: APPR
Date received: 2019-10-18
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order 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 products, to be consistent with the proposed labeling for the new Percept PC System.