PMA P100041S059

Device: SAPIEN TRANSCATHETER HEART VALVE (THV)
Applicant: Edwards Lifesciences, LLC
PMA number: P100041
Supplement: S059
Product code: NPT
Decision date: 2014-10-20
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: IMPLEMENTATION OF AN ADDITIONAL OD INSPECTION TO THE SAPIEN® AND SAPIEN XT TRANSCATHETER HEART VALVES, MODELS 9000TFX AND 9300TFX.

Current openFDA PMA Record

Device: SAPIEN TRANSCATHETER HEART VALVE (THV)
Applicant: Edwards Lifesciences, LLC
PMA number: P100041
Supplement: S059
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2014-10-20
Decision code: OK30
Date received: 2014-09-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: IMPLEMENTATION OF AN ADDITIONAL OD INSPECTION TO THE SAPIEN® AND SAPIEN XT TRANSCATHETER HEART VALVES, MODELS 9000TFX AND 9300TFX.