PMA P100041S036

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES
Applicant: Edwards Lifesciences, LLC
PMA number: P100041
Supplement: S036
Product code: NPT
Decision date: 2013-08-09
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: CHANGE TO THE QUALITY INSPECTION SAMPLING PLAN FOR THE RETROFLEX BALLOON CATHETER GUIDEWIRE SHAFT.

Current openFDA PMA Record

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES
Applicant: Edwards Lifesciences, LLC
PMA number: P100041
Supplement: S036
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2013-08-09
Decision code: OK30
Date received: 2013-07-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO THE QUALITY INSPECTION SAMPLING PLAN FOR THE RETROFLEX BALLOON CATHETER GUIDEWIRE SHAFT.