PMA P200015S006
- Device
- Edwards Commander Delivery System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P200015
- Supplement
- S006
- Product code
- NPV
- Decision date
- 2020-12-10
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Approval order statement
- Implementation of a new inspection and a new cutting fixture related to the Commander Delivery System valve crimp section.
Current openFDA PMA Record#
- Device
- Edwards Commander Delivery System
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P200015
- Supplement
- S006
- Product code
- NPV
- Generic name
- Pulmonary valve prosthesis percutaneously delivered
- Decision date
- 2020-12-10
- Decision code
- OK30
- Date received
- 2020-12-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of a new inspection and a new cutting fixture related to the Commander Delivery System valve crimp section.