PMA P110021S038

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
Applicant: Edwards Lifesciences, LLC
PMA number: P110021
Supplement: S038
Product code: NPT
Decision date: 2014-04-17
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: ADDITION OF AN ALTERNATE SELF-CONTAINED BIOLOGICAL INDICATOR IN POUCH (SCBIP) USED TO MONITOR EFFECTIVENESS OF ETHYLENE OXIDE STERILIZATION.

Current openFDA PMA Record

Device: EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
Applicant: Edwards Lifesciences, LLC
PMA number: P110021
Supplement: S038
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2014-04-17
Decision code: OK30
Date received: 2014-03-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDITION OF AN ALTERNATE SELF-CONTAINED BIOLOGICAL INDICATOR IN POUCH (SCBIP) USED TO MONITOR EFFECTIVENESS OF ETHYLENE OXIDE STERILIZATION.