- Device
- EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P110021
- Supplement
- S052
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2015-12-07
- Decision code
- APPR
- Date received
- 2015-02-09
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE CLEANING PROCESS FOR SMALL AND LARGE COMPONENTS AT THE DRAPER FACILITY.