PMA P870077S051

Device: CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE, PORCINE MITRAL BIOPROSTHESIS, CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL
Applicant: Edwards Lifesciences, LLC
Product code: DYE
Decision date: 2013-06-11
Generic name: replacement Heart-valve
Approval order statement: APPROVAL FOR THE USE OF THE RE-DESIGNED AND RE-PROGRAMMED SENSITECH TAGALERT TEMPERATURE ALARM INDICATION WITH NEW ELECTROMAGNETIC INFERENCE/ELECTROMAGNETIC DISCHARGE (EMI/ESE) PROTECTION IN THE DEVICES.

Current openFDA PMA Record

Device: CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE, PORCINE MITRAL BIOPROSTHESIS, CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL
Applicant: Edwards Lifesciences, LLC
PMA number: P870077
Supplement: S051
Product code: DYE
Generic name: replacement Heart-valve
Decision date: 2013-06-11
Decision code: APPR
Date received: 2012-12-14
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE USE OF THE RE-DESIGNED AND RE-PROGRAMMED SENSITECH TAGALERT TEMPERATURE ALARM INDICATION WITH NEW ELECTROMAGNETIC INFERENCE/ELECTROMAGNETIC DISCHARGE (EMI/ESE) PROTECTION IN THE DEVICES.