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.
Changes to the packaging configurations by reducing the number of tyvek pouched cannulae per sales carton.
| Device | LEGOO |
| Generic Name | Occluder, Internal Vessel, Temporary |
| Applicant | GENZYME CORP. |
| Date Received | 2012-10-19 |
| Decision Date | 2012-11-13 |
| PMA | P110003 |
| Supplement | S003 |
| Product Code | OBC |
| Advisory Committee | Cardiovascular |
| Supplement Type | 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 |