- Device
- Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P200015
- Supplement
- S009
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2021-04-16
- Decision code
- APPR
- Date received
- 2021-03-19
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for the Statistical Analysis Plan (SAP) for the COMPASSION S3 Post-Approval Study.