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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 NumberS014
Date Received07/06/2009
Decision Date08/12/2009
Product Code
NPZ[ Registered Establishments with NPZ ]
Advisory Committee Dental
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a manufacturing site located in shirley, new york, for the manufacture of the recombinant human platelet-derived growth factor-bb syringe and a quality testing facility at another location in shirley, new york, for the testing for the raw material, finished product release, and stability with the exception of the bioassay for the drug component of the device.
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