CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS, MODEL 3000 AORTIC

FDA premarket approval P860057/S018 · decided 2003-11-14

Approval details

PMA number

P860057

Supplement

S018

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS, MODEL 3000 AORTIC

Generic name

replacement Heart-valve

Applicant

Edwards Lifesciences, LLC

Date received

2001-10-02

Decision date

2003-11-14

Days to decision

773 days

Decision code

APPR

Product code

DYE

Advisory committee

Cardiovascular

Expedited review

No

Location

Irvine, CA

Statement

APPROVAL FOR DESIGN AND MANUFACTURING MODIFICATIONS TO THE SEWING RING/SUPPORT ASSEMBLY COMPONENTS OF THE MODEL 2800 AORTIC VALVE, SIZES 19, 21, 23, 25, 27, AND 29 MM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS, MODEL 3000 AORTIC AND IS INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC HEART VALVES USING THE SUPRA-ANNULAR OR INTRA-ANNULAR IMPLANTATION TECHNIQUE.

510(k) clearances by this applicant