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 complaint return and investigation operations to be transferred from the genzyme facility in lexington, massachusetts to the genzyme facility in farmingham, massachusetts.
| Device | FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT |
| Classification Name | Mesh, Surgical, Polymeric |
| Generic Name | Mesh, Surgical, Polymeric |
| Applicant | GENZYME CORP. |
| Date Received | 2003-11-12 |
| Decision Date | 2003-12-04 |
| PMA | P990028 |
| Supplement | S007 |
| Product Code | FTL |
| Advisory Committee | Anesthesiology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| 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 |