PMA P870077S061

Device: CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING, CARPENTIER-EDWARDS DURAFLEX LO
Applicant: Edwards Lifesciences, LLC
Product code: DYE
Decision date: 2014-05-19
Generic name: replacement Heart-valve
Approval order statement: APPROVAL FOR UPGRADING THE PRINTED CIRCUIT BOARD (PCB) OF THESENSITECH AGALERT® TEMPERATURE INDICATOR WITH MINOR HARDWARE ENHANCEMENTS.

Current openFDA PMA Record

Device: CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING, CARPENTIER-EDWARDS DURAFLEX LO
Applicant: Edwards Lifesciences, LLC
PMA number: P870077
Supplement: S061
Product code: DYE
Generic name: replacement Heart-valve
Decision date: 2014-05-19
Decision code: APPR
Date received: 2014-03-05
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR UPGRADING THE PRINTED CIRCUIT BOARD (PCB) OF THESENSITECH AGALERT® TEMPERATURE INDICATOR WITH MINOR HARDWARE ENHANCEMENTS.