- 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.