PMA P200015S079
- Device
- Edwards SAPIEN 3 Transcatheter Heart Valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P200015
- Supplement
- S079
- Product code
- NPV
- Decision date
- 2026-07-02
- Classification
- Cardiovascular
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Approval order statement
- removal of a tissue thickness measurement step from the Biosorting process
Current openFDA PMA Record#
- Device
- Edwards SAPIEN 3 Transcatheter Heart Valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P200015
- Supplement
- S079
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2026-07-02
- Decision code
- OK30
- Date received
- 2026-06-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- removal of a tissue thickness measurement step from the Biosorting process