Note: 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. |
|
Device | GEM 21S 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 | S004 |
Date Received | 05/31/2006 |
Decision Date | 07/17/2006 |
Product Code |
NPZ |
Advisory Committee |
Dental |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Other |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR A NEW ELISA PDGF-BB IDENTITY TEST. |
|
|