PMA P100041S031

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES
Applicant: Edwards Lifesciences, LLC
PMA number: P100041
Supplement: S031
Product code: NPT
Decision date: 2013-07-03
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: THREE NEW FIXTURES USED IN THE MANUFACTURING PROCESS, REMOVAL OF A DEBURR MANDREL TOOL, AND ADDITIONAL INSPECTIONS ASSOCIATED WITH THESE CHANGES.

Current openFDA PMA Record

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES
Applicant: Edwards Lifesciences, LLC
PMA number: P100041
Supplement: S031
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2013-07-03
Decision code: OK30
Date received: 2013-06-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: THREE NEW FIXTURES USED IN THE MANUFACTURING PROCESS, REMOVAL OF A DEBURR MANDREL TOOL, AND ADDITIONAL INSPECTIONS ASSOCIATED WITH THESE CHANGES.