PMA P110021S028

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES
Applicant: Edwards Lifesciences, LLC
PMA number: P110021
Supplement: S028
Product code: NPT
Decision date: 2014-03-28
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: APPROVAL FOR THREE CHANGES PERTAINING TO THE CUTTING, TOLERANCES, AND MEASUREMENT OF THE CLOTH SKIRT ON THE EDWARDS SAPIEN THV.

Current openFDA PMA Record

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES
Applicant: Edwards Lifesciences, LLC
PMA number: P110021
Supplement: S028
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2014-03-28
Decision code: APPR
Date received: 2013-09-26
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THREE CHANGES PERTAINING TO THE CUTTING, TOLERANCES, AND MEASUREMENT OF THE CLOTH SKIRT ON THE EDWARDS SAPIEN THV.