PMA P200015

Device: Edwards SAPIEN 3 Pulmonic Delivery System: 9630PL29
Applicant: Edwards Lifesciences, LLC
PMA number: P200015
Supplement: S032
Product code: NPV
Decision date: 2026-07-17
Generic name: Pulmonary valve prosthesis percutaneously delivered
Approval order statement: Approval for two manufacturing sites located at the Edwards Limerick Facility and at Sterigenics Belgium for production and sterilization of the Edwards Crimper, respectively.

Current openFDA PMA Record#

Device: Edwards SAPIEN 3 Pulmonic Delivery System: 9630PL29
Applicant: Edwards Lifesciences, LLC
PMA number: P200015
Supplement: S069
Product code: NPV
Generic name: Pulmonary valve prosthesis percutaneously delivered
Decision date: 2026-07-17
Decision code: APPR
Date received: 2025-08-06
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for two manufacturing sites located at the Edwards Limerick Facility and at Sterigenics Belgium for production and sterilization of the Edwards Crimper, respectively.