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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 NumberS010
Date Received11/21/2008
Decision Date01/20/2010
Product Code NPZ 
Advisory Committee Dental
Supplement Type135 Review Track For 30-Day Notice
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN ADDITIONAL SUPPLIER OF BOVINE ACHILLES TENDON FOR THE MANUFACTURE OF THE ABSORBABLE COLLAGEN SPONGE (ACS) COMPONENT OF THE INFUSE BONE GRAFT.
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