PMA P110021S020

Device: EDWARDS SAPIEN TRANSCATETER HEART VALVE AN TRANSFEMORAL AND TRANSAPICAL ACCESSORIES
Applicant: Edwards Lifesciences, LLC
PMA number: P110021
Supplement: S020
Product code: NPT
Decision date: 2013-07-22
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: REPLACING THE MOLD USED TO FORM THE SOFT TIP COMPONENT OF THE RETROFLEX 3 DELIVERY SYSTEM.

Current openFDA PMA Record

Device: EDWARDS SAPIEN TRANSCATETER HEART VALVE AN TRANSFEMORAL AND TRANSAPICAL ACCESSORIES
Applicant: Edwards Lifesciences, LLC
PMA number: P110021
Supplement: S020
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2013-07-22
Decision code: OK30
Date received: 2013-06-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: REPLACING THE MOLD USED TO FORM THE SOFT TIP COMPONENT OF THE RETROFLEX 3 DELIVERY SYSTEM.