PMA P140031S189

Device: Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve
Applicant: Edwards Lifesciences, LLC
PMA number: P140031
Supplement: S189
Product code: NPT
Decision date: 2026-02-03
Classification: Cardiovascular
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: Approval for a manufacturing site located at Edwards Lifesciences Costa Rica S.R.L. for RESILIA tissue processing and at Sterigenics Costa Rica S.R.L. for ethylene oxide sterilization.

Current openFDA PMA Record#

Device: Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve
Applicant: Edwards Lifesciences, LLC
PMA number: P140031
Supplement: S189
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2026-02-03
Decision code: APPR
Date received: 2025-04-28
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 Lifesciences Costa Rica S.R.L. for RESILIA tissue processing and at Sterigenics Costa Rica S.R.L. for ethylene oxide sterilization.