CARPENTIER-EDWARDS PERICARDIAL BIOPROSTHESIS, MODEL 2700

FDA premarket approval P860057/S001 · decided 1996-01-04

Approval details

PMA number

P860057

Supplement

S001

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

CARPENTIER-EDWARDS PERICARDIAL BIOPROSTHESIS, MODEL 2700

Generic name

replacement Heart-valve

Applicant

Edwards Lifesciences, LLC

Date received

1994-08-22

Decision date

1996-01-04

Days to decision

500 days

Decision code

APPR

Product code

DYE

Advisory committee

Cardiovascular

Expedited review

No

Location

Irvine, CA

Statement

APPROVAL FOR A NAME CHANGE TO THE CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESIS, MODEL 2700, AND APPROVAL FOR A REDUCED SEWING RING (RSR) VERSION OF THE VALVE WHICH WILL BE NAMED THE CARPENTIER-EDWARDS PERIMOUNT RSR BIOPROSTHESIS, MODEL 2800 AND APPROVAL FOR THE USE OF THE CURRENT MODEL 1161 VALVE SIZERS WITH THE MODEL 2800 VALVE, AND APPROVAL FOR A NEW SET OF VALVE SIZERS, MODEL 1127, FOR USE WITH THE MODEL 2700 VALVE. THE APPROVAL ALSO DISCONTINUES THE USE FO THE CURRENT DEVICE NAME, THE CARPENTI

510(k) clearances by this applicant