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 revision of storage instructions in the product label.
| Device | FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT |
| Generic Name | Mesh, Surgical, Polymeric |
| Applicant | GENZYME CORP. |
| Date Received | 2003-01-15 |
| Decision Date | 2003-02-04 |
| PMA | P990028 |
| Supplement | S006 |
| Product Code | FTL |
| Advisory Committee | Anesthesiology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | GENZYME CORP. 55 Cambridge Parkway cambridge, MA 02142 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990028 | Original Filing | |
| S007 | 2003-11-12 | Normal 180 Day Track No User Fee |
| S006 | 2003-01-15 | Special (immediate Track) |
| S005 | 2002-10-17 | Special (immediate Track) |
| S004 | ||
| S003 | ||
| S002 | 2001-01-09 | Real-time Process |
| S001 | 2000-07-28 | Normal 180 Day Track |