|
Device | GEM21S Growth Factor Enhanced Matrix |
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 | S022 |
Date Received | 03/21/2019 |
Decision Date | 08/19/2019 |
Product Code |
NPZ |
Advisory Committee |
Dental |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval to change the supplier who fills the B-TCP cup component of the GEM21S device from A+ Secure Packaging to Alliance Contract Pharma. |