PMA P200015S080
- Device
- Edwards SAPIEN 3 Transcatheter Heart Valve (9600TFX20; 9600TFX23; 9600TFX26; 9600TFX29)
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P200015
- Supplement
- S080
- Product code
- NPV
- Decision date
- 2026-07-28
- Classification
- Cardiovascular
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Approval order statement
- an update to the inspection criteria for tissue leaflets
Current openFDA PMA Record#
- Device
- Edwards SAPIEN 3 Transcatheter Heart Valve (9600TFX20; 9600TFX23; 9600TFX26; 9600TFX29)
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P200015
- Supplement
- S080
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis 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