PMA supplement
P230007 S019: TriClip™ G5 Delivery System (TCDS0801-NT, TCDS0801-NTW, TCDS0801-XT, TCDS0801-XTW)
FDA PMA supplement · Real-Time Process · ABBOTT MEDICAL
Key facts
| Original PMA | P230007 |
|---|---|
| Supplement number | S019 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | TriClip™ G5 Delivery System (TCDS0801-NT, TCDS0801-NTW, TCDS0801-XT, TCDS0801-XTW) |
| Generic name | Tricuspid valve repair device, percutaneously delivered |
| Applicant | ABBOTT MEDICAL |
| Product code | NPS |
| Received date | Nov 26, 2025 |
| Decision date | Feb 25, 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: