- Device
- Edwards Commander Delivery System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P200015
- Supplement
- S026
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2023-03-09
- Decision code
- APPR
- Date received
- 2022-08-09
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the following manufacturing sites to conduct ethylene oxide sterilization of the Commander Delivery System (Models 9600LDS23, 9750CM23, 9600LDS26, and 9750CM26): (1) Sterigenics, Belgium, located at Zoning Industriel de Petit-Rechain Avenue Andre Ernst 21 Verviers Liege, B-4800 BE, and (2) STERIS Tullamore, located at IDA Business and Technology Park, Tullamore Offaly, IE R35 X865