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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.
 
Devicei-FACTOR Peptide Enhanced Bone Graft
Generic NameFiller, bone void, synthetic peptide
ApplicantCerapedics, LLC
11025 Dover St., Suite 1600
Westminster, CO 80021
PMA NumberP140019
Supplement NumberS004
Date Received06/15/2020
Decision Date07/22/2020
Product Code NOX 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for updated labeling to include the results from the completed 72-month follow-up post-approval study.
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