Edwards Lifesciences Carpentier-Edwards PERIMOUNT Pericardial Bioprostheses

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

EDWARDS LIFESCIENCES (ASIA) PTE. LTD.

Class:

Class D medical device

Manufactured by:

Edwards Lifesciences LLC

Therapeutic area:

Cardiovascular

Therapeutic indications:

The Carpentiers-Edwards PERIMOUNT Pericardial Bioprostheses is intended for use in the patients whose aortic or mitral valvular disease is sufficiently advanced to warrant replacement of their natural valve with prosthetic one. It is also intended for use in patients with a previously implanted aortic valve prosthesis which is no longer functioning adequately and requires replacement. In the latter case, the previously implanted prosthesis is surgically excised and replaced by the replacement prosthesis.

Product summary:

Device System Info:[Sterile Medical Device], Animal origin - Bovine; Models: TRAY & HANDLE - 1173, TRAY & SIZER - 1133, HANDLE - 1111, Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprostheses, Mitral - 7300TFX, SIZER - 1173R, SIZER - 1173B, Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprostheses, Aortic - 3300TFX

Authorization date:

2011-11-11