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.
Change in the final product testing from rabbit pyrogenicity test to a limulus amebocyte lysate (lal) gel-clot test for determining the presence of endotoxins.
| Device | COLLAGRAFT STRIP BONE GRAFT MATRIX |
| Generic Name | Filler, Bone Void, Non-osteoinduction |
| Applicant | NEUCOLL, INC. |
| Date Received | 2004-12-27 |
| Decision Date | 2005-01-24 |
| PMA | P900039 |
| Supplement | S015 |
| Product Code | MBS |
| Advisory Committee | Orthopedic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |