PMA P200015S021

Device: Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent
Applicant: Edwards Lifesciences, LLC
PMA number: P200015
Supplement: S021
Product code: NPV
Decision date: 2022-06-23
Generic name: Pulmonary valve prosthesis percutaneously delivered
Approval order statement: Approval of the revised protocol for the post-approval study 2: Alterra New Enrollment Study.

Current openFDA PMA Record#

Device: Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent
Applicant: Edwards Lifesciences, LLC
PMA number: P200015
Supplement: S021
Product code: NPV
Generic name: Pulmonary valve prosthesis percutaneously delivered
Decision date: 2022-06-23
Decision code: APPR
Date received: 2022-05-25
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of the revised protocol for the post-approval study 2: Alterra New Enrollment Study.