PMA P860057S010

Device: CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL VALVE
Applicant: Edwards Lifesciences, LLC
PMA number: P860057
Supplement: S010
Product code: DYE
Decision date: 1999-04-13
Classification: Replacement Heart-valve
Generic name: replacement Heart-valve
Approval order statement: The 30-day notice requested the following manufacturing changes: 1) Modify the environmental classification for the area in which wireforming operations are performed. 2) Add a validated cleaning process for the wireform in a class 10,000 environmental prior to stent assembly.

Current openFDA PMA Record#

Device: CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL VALVE
Applicant: Edwards Lifesciences, LLC
PMA number: P860057
Supplement: S010
Product code: DYE
Generic name: replacement Heart-valve
Decision date: 1999-04-13
Decision code: OK30
Date received: 1999-03-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: The 30-day notice requested the following manufacturing changes: 1) Modify the environmental classification for the area in which wireforming operations are performed. 2) Add a validated cleaning process for the wireform in a class 10,000 environmental prior to stent assembly.