PMA P200015S064
- Device
- Edwards Commander Delivery System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P200015
- Supplement
- S064
- Product code
- NPV
- Decision date
- 2025-04-23
- Classification
- Cardiovascular
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Approval order statement
- to implement a rework loop for the delivery system subassembly to help increase yield
Current openFDA PMA Record#
- Device
- Edwards Commander Delivery System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P200015
- Supplement
- S064
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2025-04-23
- Decision code
- OK30
- Date received
- 2025-04-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to implement a rework loop for the delivery system subassembly to help increase yield