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. |
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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 | S006 |
Date Received | 08/09/2006 |
Decision Date | 09/08/2006 |
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 SCALING UP THE MANUFACTURING PROCESS TO MOVE FROM 2,000 UNIT BATCHES TO 20,000 UNIT BATCHES. |
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