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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 NameGEM 21S GROWTH FACTOR ENHANCED MATRIX
Classification Namebone grafting material, dental, with biologic component
Generic Namebone grafting material
Regulation Number872.3930
ApplicantLUITPOLD PHARMACEUTICALS, INC.
PMA NumberP040013
Supplement NumberS016
Date Received12/11/2010
Decision Date05/27/2011
Product Code
NPZ[ Registered Establishments with NPZ ]
Advisory Committee Dental
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a change in the rh-pdgf-bb syringe cap material, made by becton dickinson, the cap supplier, from west 1883 to helovet fm27, based on a change in becton dickinson rubber raw materials suppliers.
Post-Approval StudyShow Report Schedule and Study Progress
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