PMA P860057S110

Device: CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS WITH THERMAFIX TISSUE PROCESS
Applicant: Edwards Lifesciences, LLC
PMA number: P860057
Supplement: S110
Product code: DYE
Decision date: 2013-08-16
Classification: Replacement Heart-valve
Generic name: replacement Heart-valve
Approval order statement: CHANGE TO THE RESIN USED IN A COMPONENT MATERIAL IN THE TRICENTRIX HOLDER SYSTEM AND JAR ASSEMBLY.

Current openFDA PMA Record#

Device: CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS WITH THERMAFIX TISSUE PROCESS
Applicant: Edwards Lifesciences, LLC
PMA number: P860057
Supplement: S110
Product code: DYE
Generic name: replacement Heart-valve
Decision date: 2013-08-16
Decision code: OK30
Date received: 2013-07-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO THE RESIN USED IN A COMPONENT MATERIAL IN THE TRICENTRIX HOLDER SYSTEM AND JAR ASSEMBLY.