PMA P860057S118

Device: CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES
Applicant: Edwards Lifesciences, LLC
PMA number: P860057
Supplement: S118
Product code: DYE
Decision date: 2014-08-04
Classification: Replacement Heart-valve
Generic name: replacement Heart-valve
Approval order statement: APPROVAL FOR A CHANGE IN THE SANITATION FREQUENCY OF THE PROCESS WATER SYSTEM USED AT ONE OF THE MANUFACTURING FACILITIES.

Current openFDA PMA Record#

Device: CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES
Applicant: Edwards Lifesciences, LLC
PMA number: P860057
Supplement: S118
Product code: DYE
Generic name: replacement Heart-valve
Decision date: 2014-08-04
Decision code: APPR
Date received: 2014-01-29
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE IN THE SANITATION FREQUENCY OF THE PROCESS WATER SYSTEM USED AT ONE OF THE MANUFACTURING FACILITIES.