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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 NumberS043
Date Received10/17/2018
Decision Date01/15/2019
Product Code NPZ 
Advisory Committee Dental
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for an additional 6000 L bioreactor to be located in Building B, Suite CD at the Andover site.
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