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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 NumberS025
Date Received05/16/2012
Decision Date06/27/2012
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 proposed labeling revisions related to the appearance of the reconstituted product and warning statement about use in patients suspected of having cancer at the product application site.
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