Device Dossier

WaveWriter Alpha Prime 16 IMPLANTABLE PULSE GENERATOR KIT - Analgesic spinal cord electrical stimulation system pulse generator implantable

Device Dossier for WaveWriter Alpha Prime 16 IMPLANTABLE PULSE GENERATOR KIT - Analgesic spinal cord electrical stimulation system pulse generator…

Intended purpose

The WaveWriter Alpha System is indicated as an aid in the management of chronic intractable pain.

Functional description

The WaveWriter Alpha Prime 16 Implantable Pulse Generators (IPG) are intended to treat chronic pain by electrically stimulating the spinal cord or peripheral nerves. The multi-channel, multi-electrode device capability provides flexibility in conjunction with ease of programming. The IPGs are controlled by a handheld Remote Control, and can be engaged by a Clinician Programmer using proprietary programming software

TGA Public Summary