- Device
- Edwards SAPIEN 3 Pulmonic Delivery System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P200015
- Supplement
- S028
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2023-01-19
- Decision code
- APPR
- Date received
- 2022-08-31
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for adding an alternate supplier for the balloon shaft component of the Edwards Pulmonic Delivery System.