PMA P100041S061

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
Applicant: Edwards Lifesciences, LLC
PMA number: P100041
Supplement: S061
Product code: NPT
Decision date: 2014-11-25
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: EXPANSION OF THE CURRENT MANUFACTURING CLEAN ROOM ENVIRONMENT USED TO MANUFACTURE THE TRANSCATHETER HEART VALVE ACCESSORIES AT THE EDWARDS DRAPER, UTAH FACILITY.

Current openFDA PMA Record

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
Applicant: Edwards Lifesciences, LLC
PMA number: P100041
Supplement: S061
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2014-11-25
Decision code: OK30
Date received: 2014-11-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: EXPANSION OF THE CURRENT MANUFACTURING CLEAN ROOM ENVIRONMENT USED TO MANUFACTURE THE TRANSCATHETER HEART VALVE ACCESSORIES AT THE EDWARDS DRAPER, UTAH FACILITY.