PMA supplement
P130013 S065: WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl
FDA PMA supplement · Normal 180 Day Track No User Fee · Boston Scientific Corp
Key facts
| Original PMA | P130013 |
|---|---|
| Supplement number | S065 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - PAS |
| Trade name | WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl |
| Generic name | System, appendage closure, left atrial |
| Applicant | Boston Scientific Corp |
| Product code | NGV |
| Received date | Nov 13, 2023 |
| Decision date | Apr 16, 2024 |
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: