This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for a change to a sterilization process parameter.
| Device | LEGOO ENDOVASCULAR OCCLUDER |
| Generic Name | Occluder, Internal Vessel, Temporary |
| Applicant | GENZYME CORP. |
| Date Received | 2011-11-15 |
| Decision Date | 2012-03-01 |
| PMA | P110003 |
| Supplement | S001 |
| Product Code | OBC |
| Advisory Committee | Cardiovascular |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | GENZYME CORP. 52 Binney Street cambridge, MA 02142 |
| 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 |