PMA P100041S050

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
Applicant: Edwards Lifesciences, LLC
PMA number: P100041
Supplement: S050
Product code: NPT
Decision date: 2014-05-19
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: APPROVAL FOR UPGRADING THE PRINTED CIRCUIT BOARD (PCB) OF THESENSITECH AGALERT® TEMPERATURE INDICATOR WITH MINOR HARDWARE ENHANCEMENTS.

Current openFDA PMA Record

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
Applicant: Edwards Lifesciences, LLC
PMA number: P100041
Supplement: S050
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2014-05-19
Decision code: APPR
Date received: 2014-03-05
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR UPGRADING THE PRINTED CIRCUIT BOARD (PCB) OF THESENSITECH AGALERT® TEMPERATURE INDICATOR WITH MINOR HARDWARE ENHANCEMENTS.