PMA P100041S029

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE, MODEL 9000TFX
Applicant: Edwards Lifesciences, LLC
PMA number: P100041
Supplement: S029
Product code: NPT
Decision date: 2013-06-25
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: CHANGE TO THE SILICONE GASKET MATERIAL (SUPPLIED BY SAINT GOBAIN) FOR THE 3.8 OZ.JAR CAP GASKET USED IN THE FINISHED-DEVICE PACKAGING CONTAINER FOR THE EDWARDS SAPIEN VALVE.

Current openFDA PMA Record

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE, MODEL 9000TFX
Applicant: Edwards Lifesciences, LLC
PMA number: P100041
Supplement: S029
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2013-06-25
Decision code: OK30
Date received: 2013-05-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO THE SILICONE GASKET MATERIAL (SUPPLIED BY SAINT GOBAIN) FOR THE 3.8 OZ.JAR CAP GASKET USED IN THE FINISHED-DEVICE PACKAGING CONTAINER FOR THE EDWARDS SAPIEN VALVE.