- Device
- Edwards Commander Delivery System (9600LDS20, 9600LDS23, 9600LDS26, 9600LDS29)
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P200015
- Supplement
- S067
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2025-07-08
- Decision code
- OK30
- Date received
- 2025-06-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to modify the wall thickness specification of one extruded tube used in the manufacture of the Commander Delivery System