PMA supplement
P140031 S208: Edwards Certitude Delivery System (9600SDS20, 9600SDS23, 9600SDS26, 9600SDS29, 9630TA20, 9630TA23, 9630TA26, 9630TA29);
FDA PMA supplement · 30-Day Notice · Edwards Lifesciences, LLC
Key facts
| Original PMA | P140031 |
|---|---|
| Supplement number | S208 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Edwards Certitude Delivery System (9600SDS20, 9600SDS23, 9600SDS26, 9600SDS29, 9630TA20, 9630TA23, 9630TA26, 9630TA29); |
| Generic name | Aortic valve, prosthesis, percutaneously delivered |
| Applicant | Edwards Lifesciences, LLC |
| Product code | NPT |
| Received date | Jun 30, 2026 |
| Decision date | Jul 29, 2026 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: