PMA
P110003: LEGOO
FDA PMA · Occluder, internal vessel, temporary · Genzyme Corp.
Key facts
| PMA number | P110003 |
|---|---|
| Trade name | LEGOO |
| Generic name | Occluder, internal vessel, temporary |
| Applicant | Genzyme Corp. |
| Owner/operator | GENZYME CORPORATION |
| Product code | OBC |
| Approval date | Sep 28, 2011 |
| Docket number | 11M-0746 |
| Notice date | Oct 20, 2011 |
| Establishment registration | 1220423 |
| FEI number | 1220423 |
At a glance
- 1–9 Supplements
- Mar 26, 2014 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: