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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.
 
DevicePearlMatrixTM Peptide Enhanced Bone Graft
Generic NameFiller, bone void, synthetic peptide
ApplicantCerapedics, Inc.
11025 Dover St., Suite 1600
Westminster, CO 80021
PMA NumberP240001
Supplement NumberS003
Date Received08/24/2026
Decision Date09/16/2026
Product Code NOX 
Advisory Committee Orthopedic
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  
changes to the P-15 manufacturing occurring at Bachem Americas due to “…equipment technological advancements and to improve process efficiency…” , as well as a series of minor/administrative specifications changes
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