PMA P250019S006
- Device
- Edwards SAPIEN M3 Dock (988DDS); Edwards 23F Guide Sheath (9880GS); Edwards SAPIEN M3 Crimper (9880CR); Edwards Commande
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P250019
- Supplement
- S006
- Product code
- NPU
- Decision date
- 2026-07-29
- Classification
- Cardiovascular
- Generic name
- Prosthesis, mitral valve, percutaneously delivered
- Approval order statement
- automation of a component cleaning process
Current openFDA PMA Record#
- Device
- Edwards SAPIEN M3 Dock (988DDS); Edwards 23F Guide Sheath (9880GS); Edwards SAPIEN M3 Crimper (9880CR); Edwards Commande
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P250019
- Supplement
- S006
- Product code
- NPU
- Generic name
- Prosthesis, mitral valve, percutaneously delivered
- Decision date
- 2026-07-29
- Decision code
- OK30
- Date received
- 2026-06-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- automation of a component cleaning process