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 the product "neugraft". Collagraft strip bone graft matrix (collagraft) was originally approved by the fda on january 27, 1994 (review of p900039). The product currently continues to be marketed by that name. Neugraft is identical to collagraft strip bone graft matrix, except that the brand name on the labeling is different. The labeling for neugraft indicated and explains that the two products are the same, but are sold through different distribution channels. As proposed, the product will continue to be sold using both names collagraft and neugraft. There will be no change affecting safety and effectiveness for this product.
| Device | NEUGRAFT |
| Generic Name | Filler, Bone Void, Non-osteoinduction |
| Applicant | NEUCOLL, INC. |
| Date Received | 2004-04-30 |
| Decision Date | 2004-06-07 |
| PMA | P900039 |
| Supplement | S013 |
| Product Code | MBS |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |