Last synced on 13 June 2025 at 11:06 pm

Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
Edwards Lifesciences, LLC
Trade Name
Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System
Generic Name
Pulmonary valve prosthesis percutaneously delivered
Decision Date
8/31/2020
Days to Decision
175 days
Decision Code
APPR
FDA Decision
Approval

Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
Edwards Lifesciences, LLC
Trade Name
Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System
Generic Name
Pulmonary valve prosthesis percutaneously delivered
Decision Date
8/31/2020
Days to Decision
175 days
Decision Code
APPR
FDA Decision
Approval