PMA
P130013: WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY
FDA PMA · System, appendage closure, left atrial · Boston Scientific Corp
Key facts
| PMA number | P130013 |
|---|---|
| Trade name | WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY |
| Generic name | System, appendage closure, left atrial |
| Applicant | Boston Scientific Corp |
| Owner/operator | Boston Scientific Corporation |
| Product code | NGV |
| Approval date | Mar 13, 2015 |
| Docket number | 15M-0910 |
| Notice date | Mar 13, 2015 |
| Establishment registration | 2134265 |
| FEI number | 3002095335 |
At a glance
- 10–99 Supplements
- Aug 28, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: