- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P110021
- Supplement
- S053
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2015-03-20
- Decision code
- OK30
- Date received
- 2015-02-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADD A CHAMBER TO THE ETHYLENE OXIDE STERILIZATION PROCESS AT THE STERIGENICS FACILITY (SALT LAKE CITY, UTAH).