Approval for: 1) addition of a claim that pdgf stimulates angiogenesis; 2) addition of a comparison of pivotal clinical trial results obtained with gem 21s and the results published on emdogain; and 3) addition of 36 month long term efficacy data to the original 6 month study.
| Device | GEM21S GROWTH FACTOR ENHANCED |
| Classification Name | Bone Grafting Material, Dental, With Biologic Component |
| Generic Name | Bone Grafting Material, Dental, With Biologic Component |
| Applicant | Lynch Biologics LLC |
| Date Received | 2008-03-26 |
| Decision Date | 2008-08-29 |
| PMA | P040013 |
| Supplement | S013 |
| 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 | Yes |
| Applicant Address | Lynch Biologics LLC 5526 Joseph Street franklin, TN 37064 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P040013 | | Original Filing |
| S025 |
2020-11-27 |
Real-time Process |
| S024 |
2020-04-17 |
Normal 180 Day Track No User Fee |
| S023 |
2020-03-24 |
Normal 180 Day Track No User Fee |
| S022 |
2019-03-21 |
Normal 180 Day Track No User Fee |
| S021 |
2015-06-22 |
Normal 180 Day Track No User Fee |
| S020 |
2015-01-21 |
Special (immediate Track) |
| S019 |
2014-05-05 |
135 Review Track For 30-day Notice |
| S018 |
2012-02-29 |
Special (immediate Track) |
| S017 |
2011-06-24 |
Normal 180 Day Track No User Fee |
| S016 |
2010-12-11 |
Normal 180 Day Track |
| S015 |
2009-08-14 |
Normal 180 Day Track No User Fee |
| S014 |
2009-07-06 |
Normal 180 Day Track No User Fee |
| S013 |
2008-03-26 |
Normal 180 Day Track |
| S012 |
2007-11-23 |
Normal 180 Day Track No User Fee |
| S011 |
2007-05-22 |
135 Review Track For 30-day Notice |
| S010 | | |
| S009 |
2006-12-22 |
Special (immediate Track) |
| S008 |
2006-10-20 |
30-day Notice |
| S007 | | |
| S006 |
2006-08-09 |
30-day Notice |
| S005 |
2006-07-31 |
Real-time Process |
| S004 |
2006-05-31 |
Normal 180 Day Track No User Fee |
| S003 |
2006-04-06 |
Normal 180 Day Track No User Fee |
| S002 |
2006-02-27 |
Real-time Process |
| S001 | | |
NIH GUDID Devices