PMA P110021S024

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES
Applicant: Edwards Lifesciences, LLC
PMA number: P110021
Supplement: S024
Product code: NPT
Decision date: 2014-01-31
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: APPROVAL FOR A CHANGE IN MATERIAL TO THE MANDRELS USED AS MANUFACTURING AIDS FOR THE DELIVERY SYSTEM.

Current openFDA PMA Record

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES
Applicant: Edwards Lifesciences, LLC
PMA number: P110021
Supplement: S024
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2014-01-31
Decision code: APPR
Date received: 2013-07-18
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE IN MATERIAL TO THE MANDRELS USED AS MANUFACTURING AIDS FOR THE DELIVERY SYSTEM.