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: 1) the addition of a paste form of pepgen p-15, 2) modification of the device labeling for all pepgen p-15 devices, and 3) changing of the contract manufacturer for the device carrier to hyaluron, inc. , woburn, massachusetts.
| Device | PEPGEN P-15, PEPGEN P-15 FLOW, AND PEPGEN P-15 PUTTY |
| Generic Name | Bone Grafting Material, Dental, With Biologic Component |
| Applicant | CERAMED CORP. |
| Date Received | 2003-11-12 |
| Decision Date | 2004-03-15 |
| PMA | P990033 |
| Supplement | S005 |
| Product Code | NPZ |
| Advisory Committee | Dental |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CERAMED CORP. 12860 West Cedar Drive, suite 108 lakewood, CO 80228 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990033 | Original Filing | |
| S017 | 2010-06-23 | 30-day Notice |
| S016 | 2009-11-09 | 30-day Notice |
| S015 | 2007-08-20 | Normal 180 Day Track No User Fee |
| S014 | 2007-01-16 | Normal 180 Day Track No User Fee |
| S013 | ||
| S012 | ||
| S011 | ||
| S010 | ||
| S009 | ||
| S008 | 2006-08-30 | Normal 180 Day Track No User Fee |
| S007 | 2006-05-22 | Special (immediate Track) |
| S006 | ||
| S005 | 2003-11-12 | Normal 180 Day Track |
| S004 | 2002-04-22 | Normal 180 Day Track |
| S003 | 2002-01-14 | 30-day Notice |
| S002 | 2001-01-02 | Normal 180 Day Track |
| S001 | 1999-11-08 | Normal 180 Day Track |