PMA P010041S015

Device: CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS, MODEL 2650
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 S.A.V. BIOPROSTHESIS, MODEL 2650
Applicant: Edwards Lifesciences, LLC
PMA number: P010041
Supplement: S015
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.