Device Dossier

Extension Handle - Heart valve prosthesis sizer handle

Device Dossier for Extension Handle - Heart valve prosthesis sizer handle (Heart valve prosthesis sizer handle, Class III, sponsor Abbott Medical). ARTG…

Intended purpose

The Extension Handle is intended to lengthen the holder handle and sizers.

Functional description

The Extension Handle allows the physician to extend the length of the holder handle or sizers during implant procedure. The Extension Handle is designed to be bent in any direction up to 90° without degradation, allowing manipulation of the device. When the handle is exposed to the heat produced during autoclave sterilization, it will revert to its original shape.

TGA Public Summary