- Device
- Edwards Commander Delivery System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P200015
- Supplement
- S029
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2023-04-04
- Decision code
- APPR
- Date received
- 2022-09-09
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for addition of a new Edwards manufacturing facility located in Limerick, Ireland as an alternate manufacturing site for the Edwards Commander Delivery system sizes 23mm and 26mm.