PMA P140031S119
- Device
- Edwards Commander Delivery System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S119
- Product code
- NPT
- Decision date
- 2020-09-25
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Modification of acceptance criteria for in-process inspection of the valve crimp section of the Commander delivery system.
Current openFDA PMA Record#
- Device
- Edwards Commander Delivery System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S119
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2020-09-25
- Decision code
- OK30
- Date received
- 2020-09-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification of acceptance criteria for in-process inspection of the valve crimp section of the Commander delivery system.