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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 Pl.
Memphis, TN 38132
PMA NumberP050053
Supplement NumberS008
Date Received02/19/2008
Decision Date05/13/2008
Product Code NPZ 
Advisory Committee Dental
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR LABELING MODIFICATIONS TO ADDRESS WARNINGS ABOUT IMPROPER PREPARATION OF INFUSE BONE GRAFT AND OVERFILLING OF BONE DEFECTS.
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