PMA P200015S070

Device: Edwards Commander Delivery System: 9600LDS23, 9600LDS26, 9600LDS29 9750CM23, 9750CM26, 9750CM29
Applicant: Edwards Lifesciences, LLC
PMA number: P200015
Supplement: S070
Product code: NPV
Decision date: 2025-10-02
Classification: Cardiovascular
Generic name: Pulmonary valve prosthesis percutaneously delivered
Approval order statement: the addition of a new Ethylene Oxide (EO) Sterilization Line at the existing and approved EO sterilization facility

Current openFDA PMA Record#

Device: Edwards Commander Delivery System: 9600LDS23, 9600LDS26, 9600LDS29 9750CM23, 9750CM26, 9750CM29
Applicant: Edwards Lifesciences, LLC
PMA number: P200015
Supplement: S070
Product code: NPV
Generic name: Pulmonary valve prosthesis percutaneously delivered
Decision date: 2025-10-02
Decision code: OK30
Date received: 2025-09-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the addition of a new Ethylene Oxide (EO) Sterilization Line at the existing and approved EO sterilization facility