PMA supplement
P110003 S001: LEGOO ENDOVASCULAR OCCLUDER
FDA PMA supplement · 135 Review Track For 30-Day Notice · Genzyme Corp.
Key facts
| Original PMA | P110003 |
|---|---|
| Supplement number | S001 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | LEGOO ENDOVASCULAR OCCLUDER |
| Generic name | Occluder, internal vessel, temporary |
| Applicant | Genzyme Corp. |
| Product code | OBC |
| Received date | Nov 15, 2011 |
| Decision date | Mar 1, 2012 |
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: