PMA P100041S043

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES
Applicant: Edwards Lifesciences, LLC
PMA number: P100041
Supplement: S043
Product code: NPT
Decision date: 2013-11-18
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: APPROVAL FOR MODIFYING INSPECTION OF THE Y-CONNECTOR TO GUIDEWIRE SHAFT AND ASSOCIATED CHANGES TO THE MANUFACTURING PROCEDURE DOCUMENTATION.

Current openFDA PMA Record

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES
Applicant: Edwards Lifesciences, LLC
PMA number: P100041
Supplement: S043
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2013-11-18
Decision code: APPR
Date received: 2013-10-22
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR MODIFYING INSPECTION OF THE Y-CONNECTOR TO GUIDEWIRE SHAFT AND ASSOCIATED CHANGES TO THE MANUFACTURING PROCEDURE DOCUMENTATION.