- Device
- Edwards SAPIEN M3 Transcatheter Heart Valve (sizes 20mm, 23mm, 26mm, 29mm)
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P250019
- Supplement
- S002
- Product code
- NPU
- Generic name
- Prosthesis, mitral valve, percutaneously delivered
- Decision date
- 2026-03-11
- Decision code
- OK30
- Date received
- 2026-02-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- alternate suppliers of solutions used in the manufacturing process of transcatheter and surgical heart valves