PMA P110021S014

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES RETROFLEX 3 DELIVERY SYSTEM
Applicant: Edwards Lifesciences, LLC
PMA number: P110021
Supplement: S014
Product code: NPT
Decision date: 2013-06-10
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: APPROVAL FOR A CHANGE IN THE STENT LENGTH SPECIFICATION AND CHANGES TO THE PRODUCT LABELING WHICH INCLUDED A CHANGE TO THE LABELED LENGTH OF THE STENT AND MINOR EDITORIAL MODIFICATIONS.

Current openFDA PMA Record

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES RETROFLEX 3 DELIVERY SYSTEM
Applicant: Edwards Lifesciences, LLC
PMA number: P110021
Supplement: S014
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2013-06-10
Decision code: APPR
Date received: 2013-05-16
Supplement type: Special (Immediate Track)
Approval order statement: APPROVAL FOR A CHANGE IN THE STENT LENGTH SPECIFICATION AND CHANGES TO THE PRODUCT LABELING WHICH INCLUDED A CHANGE TO THE LABELED LENGTH OF THE STENT AND MINOR EDITORIAL MODIFICATIONS.