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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 ENHANCED MATRIX)
Classification Namebone grafting material, dental, with biologic component
Generic Namebone grafting material
Regulation Number872.3930
ApplicantBIOMIMETIC THERAPEUTICS, INC.
PMA NumberP040013
Supplement NumberS009
Date Received12/22/2006
Decision Date08/10/2007
Product Code
NPZ[ Registered Establishments with NPZ ]
Advisory Committee Dental
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the new reference standard, which is used in the following analytical methods: rp-hplc, sec, sds-page, uv, bioassay, elisa, and phh.
Post-Approval StudyShow Report Schedule and Study Progress
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