- Device
- Edwards SAPIEN 3 Transcatheter Heart Valve System and Accessories
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P200015
- Supplement
- S031
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2022-11-16
- Decision code
- OK30
- Date received
- 2022-10-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification to the in-process acceptance criteria and inspection method for tissue separations on the leaflet free edge of the SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA transcatheter heart valves.