PMA P250019S005
- Device
- SAPIEN M3 Transcatheter Heart Valve (9880TFX29M)
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P250019
- Supplement
- S005
- Product code
- NPU
- Decision date
- 2026-07-28
- Classification
- Cardiovascular
- Generic name
- Prosthesis, mitral valve, percutaneously delivered
- Approval order statement
- an update to the inspection criteria for tissue leaflets
Current openFDA PMA Record#
- Device
- SAPIEN M3 Transcatheter Heart Valve (9880TFX29M)
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P250019
- Supplement
- S005
- Product code
- NPU
- Generic name
- Prosthesis, mitral valve, percutaneously delivered
- Decision date
- 2026-07-28
- Decision code
- OK30
- Date received
- 2026-06-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an update to the inspection criteria for tissue leaflets