|
Device | GEM21S GROWTH FACTOR ENHANCED |
Generic Name | Bone grafting material, dental, with biologic component |
Regulation Number | 872.3930 |
Applicant | Lynch Biologics LLC 5526 Joseph Street Franklin, TN 37064 |
PMA Number | P040013 |
Supplement Number | S013 |
Date Received | 03/26/2008 |
Decision Date | 08/29/2008 |
Product Code |
NPZ |
Advisory Committee |
Dental |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement 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. |