PMA P100041S021

Device: SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES
Applicant: Edwards Lifesciences, LLC
PMA number: P100041
Supplement: S021
Product code: NPT
Decision date: 2013-02-08
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: CHANGES AFFECTING THE SUPPLIERS OF THE RAW MATERIALS FOR POLYPROPYLENE MONOFILAMENT THREAD, POLYETHYLENE TEREPHTHALATE WOVEN RIBBON, AND VESTAMID RESIN.

Current openFDA PMA Record

Device: SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES
Applicant: Edwards Lifesciences, LLC
PMA number: P100041
Supplement: S021
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2013-02-08
Decision code: OK30
Date received: 2013-01-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGES AFFECTING THE SUPPLIERS OF THE RAW MATERIALS FOR POLYPROPYLENE MONOFILAMENT THREAD, POLYETHYLENE TEREPHTHALATE WOVEN RIBBON, AND VESTAMID RESIN.