PMA P200015S022

Device: Edwards Alterra Adaptive Prestent System
Applicant: Edwards Lifesciences, LLC
PMA number: P200015
Supplement: S022
Product code: NPV
Decision date: 2022-07-06
Generic name: Pulmonary valve prosthesis percutaneously delivered
Approval order statement: Changes to the Alterra prestent visual receiving inspection acceptance criteria and the austenite start temperature specification of the nitinol ingots used to manufacture the frame.

Current openFDA PMA Record#

Device: Edwards Alterra Adaptive Prestent System
Applicant: Edwards Lifesciences, LLC
PMA number: P200015
Supplement: S022
Product code: NPV
Generic name: Pulmonary valve prosthesis percutaneously delivered
Decision date: 2022-07-06
Decision code: OK30
Date received: 2022-06-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Changes to the Alterra prestent visual receiving inspection acceptance criteria and the austenite start temperature specification of the nitinol ingots used to manufacture the frame.