- Device
- Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P200015
- Supplement
- S065
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2025-05-20
- Decision code
- OK30
- Date received
- 2025-04-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of a programmed recipe to perform dimensional verification of packaging jars