CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERCARDIAL BIOPRSTHESIS MODELS 7300 AND 7300TFX

FDA premarket approval P860057/S068 · decided 2010-06-24

Approval details

PMA number

P860057

Supplement

S068

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERCARDIAL BIOPRSTHESIS MODELS 7300 AND 7300TFX

Generic name

replacement Heart-valve

Applicant

Edwards Lifesciences, LLC

Date received

2010-04-26

Decision date

2010-06-24

Days to decision

59 days

Decision code

APPR

Product code

DYE

Advisory committee

Cardiovascular

Expedited review

No

Location

Irvine, CA

Statement

APPROVAL FOR A NEW MITRAL VALVE MODEL TO BE ADDED TO THE CARPENTIER-EDWARDS PERIMOUNT VALVE SERIES, WHICH INCORPORATES A NEW SUTURE GUIDE LINE, A HYBRID CLIP, A MODIFIED JAR, A MODIFIED SLEEVE, A HYBRID HOLDER, AND MODIFIED ACCESSORIES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESES, MODELS 7300 & 7300TFX, AND IS INDICATED FOR PATIENTS WHO REQUIRE REPLACEMENT OF THEIR NATIVE OR PROSTHETIC MITRAL VALVE.

510(k) clearances by this applicant