|
Device | GEM 21S GROWTH FACTOR ENHANCED MATRIX RHPDGF-BB COMPONENT |
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 | S008 |
Date Received | 10/20/2006 |
Decision Date | 11/17/2006 |
Product Code |
NPZ |
Advisory Committee |
Dental |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement ADD AAI PHARMA-WILMINGTON FACILITY AS A QUALIFIED FACILITY TO CONDUCT A BIOASSAY ON THE DRUG COMPONENT OF THE DEVICE. |