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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameGEM21S GROWTH FACTOR ENHANCED
Classification Namebone grafting material, dental, with biologic component
Generic Namebone grafting material
Regulation Number872.3930
ApplicantLUITPOLD PHARMACEUTICALS, INC.
PMA NumberP040013
Supplement NumberS013
Date Received03/26/2008
Decision Date08/29/2008
Product Code
NPZ[ Registered Establishments with NPZ ]
Advisory Committee Dental
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
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.
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