PMA P860057S132

Device: CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, WITH THERMAFIX TISSUE PROCESS, RSR PERICARDIAL AORTIC BIO
Applicant: Edwards Lifesciences, LLC
PMA number: P860057
Supplement: S132
Product code: DYE
Decision date: 2015-02-11
Classification: Replacement Heart-valve
Generic name: replacement Heart-valve
Approval order statement: UPGRADE TO THE LABELING SOFTWARE USED TO GENERATE FINISHED DEVICE LABELS.

Current openFDA PMA Record#

Device: CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, WITH THERMAFIX TISSUE PROCESS, RSR PERICARDIAL AORTIC BIO
Applicant: Edwards Lifesciences, LLC
PMA number: P860057
Supplement: S132
Product code: DYE
Generic name: replacement Heart-valve
Decision date: 2015-02-11
Decision code: OK30
Date received: 2015-01-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: UPGRADE TO THE LABELING SOFTWARE USED TO GENERATE FINISHED DEVICE LABELS.