PMA P240001

Device: PearlMatrixTM Peptide Enhanced Bone Graft
Applicant: Cerapedics, Inc.
Product code: NOX
Decision date: 2026-09-16
Generic name: Filler, bone void, synthetic peptide
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

Current openFDA PMA Record#

Device: PearlMatrixTM Peptide Enhanced Bone Graft
Applicant: Cerapedics, Inc.
PMA number: P240001
Supplement: S003
Product code: NOX
Generic name: Filler, bone void, synthetic peptide
Decision date: 2026-09-16
Decision code: OK30
Date received: 2026-08-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
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