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 the addition of a box around the contraindications section of the instructions for use for focalseal-l sealant.
Device | FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT |
Generic Name | Mesh, Surgical, Polymeric |
Applicant | GENZYME CORP. |
Date Received | 2002-10-17 |
Decision Date | 2002-11-25 |
PMA | P990028 |
Supplement | S005 |
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 |