PMA P140031S136
- Device
- Edwards SAPIEN 3 transcatheter heart valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S136
- Product code
- NPT
- Decision date
- 2021-10-28
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Changes to the manufacturing process for several components of the Edwards Commander delivery system.
Current openFDA PMA Record#
- Device
- Edwards SAPIEN 3 transcatheter heart valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S136
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2021-10-28
- Decision code
- OK30
- Date received
- 2021-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the manufacturing process for several components of the Edwards Commander delivery system.