- Device
- Edwards SAPIEN 3™ Transcatheter Heart Valve and SAPIEN 3 Ultra™ Transcatheter Heart Valve.
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S135
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2021-10-12
- Decision code
- OK30
- Date received
- 2021-09-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Increased manning and a relocation of component manufacturing activities to cleanroom #2-1.