Device Dossier

Epic Valve Aortic Model E100 - Aortic heart valve bioprosthesis

Device Dossier for Epic Valve Aortic Model E100 - Aortic heart valve bioprosthesis (Aortic heart valve bioprosthesis, Class III, sponsor Abbott Medical).…

Intended purpose

The SJM Epic Aortic Valve is intended as a replacement for a diseased, damaged or malformed aortic native heart valve. It may also be used as a replacement for a previously implanted aortic prosthetic heart valve.

Functional description

The SJM Epic Aortic Valve is a triple-composite bioprosethetic heart valve manufactured from select porcine aortic valve cusps.

TGA Public Summary