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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 NumberS035
Date Received06/21/2016
Decision Date09/16/2016
Product Code NPZ 
Advisory Committee Dental
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for increasing the size of the bioreactor used to manufacture rhBMP-2 from 6000 L to 12,000 L at the Pfizer Andover, Massachusetts facility.
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