PMA P100041S024

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE
Applicant: Edwards Lifesciences, LLC
PMA number: P100041
Supplement: S024
Product code: NPT
Decision date: 2013-04-18
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: APPROVAL FOR IMPLEMENTATION OF MORE DETAILED CRIMPER MANUFACTURING INSTRUCTIONS AND ADDITIONAL QUALITY CONTROL STEPS TO ENHANCE THE SAFETY OF THE CRIMPER DEVICES.

Current openFDA PMA Record

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE
Applicant: Edwards Lifesciences, LLC
PMA number: P100041
Supplement: S024
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2013-04-18
Decision code: APPR
Date received: 2013-03-28
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR IMPLEMENTATION OF MORE DETAILED CRIMPER MANUFACTURING INSTRUCTIONS AND ADDITIONAL QUALITY CONTROL STEPS TO ENHANCE THE SAFETY OF THE CRIMPER DEVICES.