PMA P200015S019

Device: Edwards Alterra Adaptive Prestent System
Applicant: Edwards Lifesciences, LLC
PMA number: P200015
Supplement: S019
Product code: NPV
Decision date: 2022-04-08
Generic name: Pulmonary valve prosthesis percutaneously delivered
Approval order statement: Modification to the inspection method of the Alterra Delivery System inner shaft from use of a Keyence system to a laser micrometer.

Current openFDA PMA Record#

Device: Edwards Alterra Adaptive Prestent System
Applicant: Edwards Lifesciences, LLC
PMA number: P200015
Supplement: S019
Product code: NPV
Generic name: Pulmonary valve prosthesis percutaneously delivered
Decision date: 2022-04-08
Decision code: OK30
Date received: 2022-04-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Modification to the inspection method of the Alterra Delivery System inner shaft from use of a Keyence system to a laser micrometer.