PMA P860057S223

Device: Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Bioprosthesis; Carpentier-Edwards PERIMOUNT Plus Mitral Bioprosthesi
Applicant: Edwards Lifesciences, LLC
PMA number: P860057
Supplement: S223
Product code: DYE
Decision date: 2025-10-16
Classification: Cardiovascular
Generic name: replacement Heart-valve
Approval order statement: addition of final bioburden reduction and preliminary packaging processes to an existing cleanroom, and increased maximum capacity in the cleanroom

Current openFDA PMA Record#

Device: Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Bioprosthesis; Carpentier-Edwards PERIMOUNT Plus Mitral Bioprosthesi
Applicant: Edwards Lifesciences, LLC
PMA number: P860057
Supplement: S223
Product code: DYE
Generic name: replacement Heart-valve
Decision date: 2025-10-16
Decision code: OK30
Date received: 2025-09-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: addition of final bioburden reduction and preliminary packaging processes to an existing cleanroom, and increased maximum capacity in the cleanroom