PMA P140031S147
- Device
- Edwards Certitude Introducer Sheath Set
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S147
- Product code
- NPT
- Decision date
- 2022-10-26
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Change to the hub material for the overmold introducer.
Current openFDA PMA Record#
- Device
- Edwards Certitude Introducer Sheath Set
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S147
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2022-10-26
- Decision code
- OK30
- Date received
- 2022-09-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the hub material for the overmold introducer.