PMA P110021S004

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSAPICAL AND TRANSFEMORAL ACCESSORIES
Applicant: Edwards Lifesciences, LLC
PMA number: P110021
Supplement: S004
Product code: NPT
Decision date: 2013-07-02
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: APPROVAL FOR DESIGN MODIFICATIONS TO THE ASCENDRA BALLOON CATHETER, MODELS 9100BCL23 (23MM) AND 9100BCL26 (26MM), AND THE ASCENDRA INTRODUCER SHEATH SET, MODEL 91001S. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ASCENDRA 3 DELIVERY SYSTEM, MODELS 9120AS23 (23MM) AND 9120AS26 (26MM) AND ASCENDRA 3 INTRODUCER SHEATH SET, MODEL 9120IS (26F) AND IS INDICATEDFOR THE TRANSAPICAL DELIVERY OF THE EDWARDS SAPIEN TRANSCATHETER HEART VALVE (DELIVERY SYSTEM) AND FOR THE INTRODUCTION AND REMOVAL OF DEVICES USED WITH THE EDWARDS SAPIEN TRANSCATHETER HEART VALVE (INTRODUCER SHEATH SET).

Current openFDA PMA Record

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSAPICAL AND TRANSFEMORAL ACCESSORIES
Applicant: Edwards Lifesciences, LLC
PMA number: P110021
Supplement: S004
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2013-07-02
Decision code: APPR
Date received: 2012-12-04
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR DESIGN MODIFICATIONS TO THE ASCENDRA BALLOON CATHETER, MODELS 9100BCL23 (23MM) AND 9100BCL26 (26MM), AND THE ASCENDRA INTRODUCER SHEATH SET, MODEL 91001S. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ASCENDRA 3 DELIVERY SYSTEM, MODELS 9120AS23 (23MM) AND 9120AS26 (26MM) AND ASCENDRA 3 INTRODUCER SHEATH SET, MODEL 9120IS (26F) AND IS INDICATEDFOR THE TRANSAPICAL DELIVERY OF THE EDWARDS SAPIEN TRANSCATHETER HEART VALVE (DELIVERY SYSTEM) AND FOR THE INTRODUCTION AND REMOVAL OF DEVICES USED WITH THE EDWARDS SAPIEN TRANSCATHETER HEART VALVE (INTRODUCER SHEATH SET).