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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceINFUSE BONE GRAFT
Generic NameBone grafting material, dental, with biologic component
Regulation Number872.3930
ApplicantMEDTRONIC Inc.
1800 Pyramid Place
Memphis, TN 38132
PMA NumberP050053
Supplement NumberS025
Date Received05/16/2012
Decision Date06/27/2012
Product Code NPZ 
Advisory Committee Dental
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
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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