- Device
- SAPIEN 3 Ultra Transcatheter Heart Valve System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S099
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2021-01-27
- Decision code
- APPR
- Date received
- 2019-10-21
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the Edwards Costa Rica manufacturing site to manufacture the SAPIEN 3 Ultra transcatheter heart valve (Model 9750TFX, sizes 20mm, 23mm, and 26mm), located at:Zona Franca La Lima, De la entrada de Pequeno Mundo 100 mts oeste y 200 mts surFinca 31 y 32Guadalupe, CartagoCosta Rica 30106