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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
ApplicantBoston Scientific Corp
100 Boston Scientific Way
Marlboro, MA 01752
PMA NumberP050053
Supplement NumberS040
Date Received11/13/2017
Decision Date12/13/2017
Product Code NPZ 
Advisory Committee Dental
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Source manufacturing changes to the absorbable collagen sponge component of Infuse Bone Graft.
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