PMA P860057S045

Device: CARPENTIER-EDWARDS, THEON, RSR, THEON RSR, MAGNA, PLUS MITRAL, THEON MITRAL PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS
Applicant: Edwards Lifesciences, LLC
PMA number: P860057
Supplement: S045
Product code: DYE
Decision date: 2008-05-23
Classification: Replacement Heart-valve
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, THEON, RSR, THEON RSR, MAGNA, PLUS MITRAL, THEON MITRAL PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS
Applicant: Edwards Lifesciences, LLC
PMA number: P860057
Supplement: S045
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: Change Design/Components/Specifications/Material
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.