PMA P110021S034

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE
Applicant: Edwards Lifesciences, LLC
PMA number: P110021
Supplement: S034
Product code: NPT
Decision date: 2014-02-12
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: APPROVAL FOR THE ADDITION OF LABELING TO INDICATE THE CONTENTS OF DRY NATURAL RUBBER IN THE DEVICE PACKAGING.

Current openFDA PMA Record

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE
Applicant: Edwards Lifesciences, LLC
PMA number: P110021
Supplement: S034
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2014-02-12
Decision code: APPR
Date received: 2014-01-15
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE ADDITION OF LABELING TO INDICATE THE CONTENTS OF DRY NATURAL RUBBER IN THE DEVICE PACKAGING.