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 following indications for use; augmentation of bony defects of the alveolar ridge, filling tooth extraction sites, and sinus elevation grafting. The device, as modified, will be marketed under the trade names pepgen p-15 and pepgen p-15 flow.
| Device | PEPGEN P-15 AND PEPGEN P-15 FLOW |
| Generic Name | Bone Grafting Material, Dental, With Biologic Component |
| Applicant | CERAMED CORP. |
| Date Received | 2002-04-22 |
| Decision Date | 2002-06-14 |
| PMA | P990033 |
| Supplement | S004 |
| Product Code | NPZ |
| Advisory Committee | Dental |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |