Device Dossier

Unclassified

Device Dossier for Unclassified (Unclassified, Class IIa, sponsor Medtronic). ARTG record, intended purpose, GMDN category — compiled by arcimedes.

Intended purpose

This device is intended to position and stabilise the heart, to enable the doctor to perform beating heart surgery for such procedures as coronary artery bypass grafting. The device is preformed around an area of the heart and a vacuum being exerted on the inside achieves the stabilisation and/or positioning of the heart. The device is supplied with a vapour trap and tubing to protect the vacuum equipment during the procedure.

TGA Public Summary