PMA P150048S065

Device: Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesi
Applicant: Edwards Lifesciences, LLC
Product code: LWR
Decision date: 2022-09-08
Generic name: heart-valve, non-allograft tissue
Approval order statement: Approval for a manufacturing site located at Edwards Costa Rica Cartago (Zona Franca La Lima, De La Entrada De Pequeno Mundo 100 Mts Oeste Y 200 Mts Sur Finca 31 Y 32 Guadalupe Cartago 30106 CR) for subassembly of bioprosthetic heart valves.

Current openFDA PMA Record#

Device: Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesi
Applicant: Edwards Lifesciences, LLC
PMA number: P150048
Supplement: S065
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2022-09-08
Decision code: APPR
Date received: 2022-06-03
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at Edwards Costa Rica Cartago (Zona Franca La Lima, De La Entrada De Pequeno Mundo 100 Mts Oeste Y 200 Mts Sur Finca 31 Y 32 Guadalupe Cartago 30106 CR) for subassembly of bioprosthetic heart valves.