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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.
 
DevicePearlMatrix™ Peptide Enhanced Bone Graft
Generic NameFiller, bone void, synthetic peptide
ApplicantCerapedics, Inc.
11025 Dover St., Suite 1600
Westminster, CO 80021
PMA NumberP240001
Supplement NumberS002
Date Received04/01/2026
Decision Date04/07/2026
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  
Change in the location for performance of the mass spectral analysis for the P-15 drug substance release specification from SGS North America (NAM), Inc, West Chester PA as a contract laboratory to Bachem Americas to being performed inhouse at Bachem Americas, Torrence, CA
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