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 changes to your manufacturing process. These changes involve 1) moving some of the manufacturing operations currently performed in a class 100 room to a "controlled" environment that provides the equivalent of a class 10,000 environment, 2) increasing the "hold" time between the remisturization and irradiation processes, and 3) eliminating both the protein concentration assay for past homogenate mixing and the lal pyrogenicity assay, as described in the supplement.
| Device | COLLAGRAFT STRIP BONE GRAFT MATRIX |
| Generic Name | Filler, Bone Void, Non-osteoinduction |
| Applicant | NEUCOLL, INC. |
| Date Received | 1998-11-23 |
| Decision Date | 1998-12-07 |
| PMA | P900039 |
| Supplement | S010 |
| Product Code | MBS |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| 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 |