PMA supplement
P130013 S035: WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System and WATCHMAN Left Atrial Appendage Closure Device
FDA PMA supplement · Panel Track · Boston Scientific Corp
Key facts
| Original PMA | P130013 |
|---|---|
| Supplement number | S035 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System and WATCHMAN Left Atrial Appendage Closure Device |
| Generic name | System, appendage closure, left atrial |
| Applicant | Boston Scientific Corp |
| Product code | NGV |
| Received date | Jan 2, 2020 |
| Decision date | Jul 21, 2020 |
| Docket number | 20M-1715 |
| Notice date | Jul 30, 2020 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: