PMA P140031S148
- Device
- Edwards Commander Delivery System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S148
- Product code
- NPT
- Decision date
- 2022-10-24
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Implementation of Commander Delivery System Flex Shaft subassembly manufacturing at the Edwards Draper, UT facility.
Current openFDA PMA Record#
- Device
- Edwards Commander Delivery System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S148
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2022-10-24
- Decision code
- OK30
- Date received
- 2022-10-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of Commander Delivery System Flex Shaft subassembly manufacturing at the Edwards Draper, UT facility.