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 manufacturing facility located at chesapeake biological laboratories, inc. , baltimore, md. The facility will perform the aseptic formulation and filling of primer vial 2 of focalseal-l synthetic absorbable sealant.
| Device | FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT |
| Classification Name | Mesh, Surgical, Polymeric |
| Generic Name | Mesh, Surgical, Polymeric |
| Applicant | GENZYME CORP. |
| Date Received | 2001-01-09 |
| Decision Date | 2001-07-16 |
| PMA | P990028 |
| Supplement | S002 |
| Product Code | FTL |
| Advisory Committee | Anesthesiology |
| Supplement Type | Real-time Process |
| Supplement Reason | Process 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 |