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 focalseal-l synthetic absorbable sealant.
| Device | FOCAL SEAL-L SYNTHETIC ABSORBABLE SEALANT |
| Classification Name | Sealant, Polymerizing |
| Generic Name | Sealant, Polymerizing |
| Applicant | GENZYME CORP. |
| Date Received | 1999-06-07 |
| Decision Date | 2000-05-26 |
| Notice Date | 2000-09-11 |
| PMA | P990028 |
| Supplement | S |
| Product Code | NBE |
| Docket Number | 00M-1507 |
| Advisory Committee | General & Plastic Surgery |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | GENZYME CORP. 55 Cambridge Parkway cambridge, MA 02142 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| 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 |