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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 NameINFUSE BONE GRAFT
Classification Namebone grafting material, dental, with biologic component
Regulation Number872.3930
Applicant MEDTRONIC INC.
PMA NumberP050053
Supplement NumberS005
Date Received11/13/2007
Decision Date08/15/2008
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 at integra neurosciences pr, inc. , anasco, puerto rico, and a sterilizing site at steritech, inc. , salinas, puerto rico.
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