PMA P870077S013

Device: CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS
Applicant: Edwards Lifesciences, LLC
Product code: DYE
Decision date: 2003-05-09
Generic name: replacement Heart-valve
Approval order statement: APPROVAL FOR THE REPLACEMENT OF THE PACKAGE TEMPERATURE INDICATOR TO THE TAGALERT ELECTRONIC TEMPERATURE INDICATOR (HIGH AND LOW).

Current openFDA PMA Record

Device: CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS
Applicant: Edwards Lifesciences, LLC
PMA number: P870077
Supplement: S013
Product code: DYE
Generic name: replacement Heart-valve
Decision date: 2003-05-09
Decision code: APPR
Date received: 2002-11-12
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE REPLACEMENT OF THE PACKAGE TEMPERATURE INDICATOR TO THE TAGALERT ELECTRONIC TEMPERATURE INDICATOR (HIGH AND LOW).