PMA P870077S027

Device: CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS, MODEL 6625 LP & MODEL 6625 ESR-LP
Applicant: Edwards Lifesciences, LLC
Product code: DYE
Decision date: 2008-05-23
Generic name: replacement Heart-valve
Approval order statement: APPROVAL TO EXTEND THE USE OF THE SENSITECH TAGALERT TEMPERATURE ALARM INDICATOR ON THE DEVICE PACKAGING FROM TRANSIT ONLY TO BOTH TRANSIT AND STORAGE UP TO FOUR (4) YEARS.

Current openFDA PMA Record

Device: CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS, MODEL 6625 LP & MODEL 6625 ESR-LP
Applicant: Edwards Lifesciences, LLC
PMA number: P870077
Supplement: S027
Product code: DYE
Generic name: replacement Heart-valve
Decision date: 2008-05-23
Decision code: APPR
Date received: 2008-03-24
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL TO EXTEND THE USE OF THE SENSITECH TAGALERT TEMPERATURE ALARM INDICATOR ON THE DEVICE PACKAGING FROM TRANSIT ONLY TO BOTH TRANSIT AND STORAGE UP TO FOUR (4) YEARS.