PMA P140031S208
- Device
- Edwards Certitude Delivery System (9600SDS20, 9600SDS23, 9600SDS26, 9600SDS29, 9630TA20, 9630TA23, 9630TA26, 9630TA29);
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S208
- Product code
- NPT
- Decision date
- 2026-07-29
- Classification
- Cardiovascular
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- automation of a component cleaning process
Current openFDA PMA Record#
- Device
- Edwards Certitude Delivery System (9600SDS20, 9600SDS23, 9600SDS26, 9600SDS29, 9630TA20, 9630TA23, 9630TA26, 9630TA29);
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S208
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2026-07-29
- Decision code
- OK30
- Date received
- 2026-06-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- automation of a component cleaning process