- Device
- Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S151
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2023-01-20
- Decision code
- APPR
- Date received
- 2023-01-05
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at 35 Changi North Crescent, Changi South East, SG 499641 (Edwards Lifesciences Singapore Pte Ltd.) for RESILIA tissue processing.