Device Dossier

Personal Therapy Manager 8835 - Active-implantable-device communicator

Device Dossier for Personal Therapy Manager 8835 - Active-implantable-device communicator (Active-implantable-device communicator, Class III, sponsor…

Intended purpose

The 8835 Personal Therapy Manager is a hand held device for the patient that can be used with a Medtronic Synchromed II Infusion System. The patient uses the Personal Therapy Manager to deliver physician programmed doses of medication as a supplement to continuous infusion. A personal therapy manager is to be used by a single patient.

Functional description

The Personal Therapy Manager 8835 enables a patient to request a prescribed and programmed dose of medication from the implanted Synchromed II programmable pump. The dose of medication activated by the Personal Therapy Manager suppliments the contiunuous infusion of medication supplied by the implanted pump.

TGA Public Summary