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.
| Device | COLLAGRAFT(TM) BONE GRAFT SUBSTITUTE |
| Generic Name | Filler, Bone Void, Non-osteoinduction |
| Applicant | NEUCOLL, INC. |
| Date Received | 1990-05-25 |
| Decision Date | 1993-05-28 |
| Notice Date | 1993-07-22 |
| PMA | P900039 |
| Supplement | S |
| Product Code | MBS |
| Docket Number | 93M-0210 |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | NEUCOLL, INC. 105 Cooper Ct. los Gatos, CA 95032-7604 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P900039 | Original Filing | |
| S015 | 2004-12-27 | 30-day Notice |
| S014 | ||
| S013 | 2004-04-30 | Normal 180 Day Track No User Fee |
| S012 | 2002-09-12 | 30-day Notice |
| S011 | 2001-09-19 | Normal 180 Day Track |
| S010 | 1998-11-23 | Real-time Process |
| S009 | 1995-10-10 | Normal 180 Day Track |
| S008 | 1995-07-28 | Normal 180 Day Track |
| S007 | 1995-01-24 | Special (immediate Track) |
| S006 | 1994-11-01 | Normal 180 Day Track |
| S005 | 1994-09-20 | Special (immediate Track) |
| S004 | ||
| S003 | 1993-10-01 | Normal 180 Day Track |
| S002 | 1993-07-02 | Normal 180 Day Track |
| S001 | 1992-12-03 | Normal 180 Day Track |