This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the legoo. This device is indicated for temporary endovascular occlusion of blood vessels below the neck up to 4 mm in diameter.
| Device | LEGOO |
| Generic Name | Occluder, Internal Vessel, Temporary |
| Applicant | GENZYME CORP. |
| Date Received | 2011-01-31 |
| Decision Date | 2011-09-28 |
| Notice Date | 2011-10-20 |
| PMA | P110003 |
| Supplement | S |
| Product Code | OBC |
| Docket Number | 11M-0746 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | GENZYME CORP. 52 Binney Street cambridge, MA 02142 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110003 | Original Filing | |
| S004 | 2014-02-27 | 30-day Notice |
| S003 | 2012-10-19 | 30-day Notice |
| S002 | 2012-10-15 | 30-day Notice |
| S001 | 2011-11-15 | 135 Review Track For 30-day Notice |