PMA supplement
P240001 S001: PearlMatrix™ P-15 Peptide Enhanced Bone Graft (PearlMatrix™ Bone Graft)
FDA PMA supplement · Normal 180 Day Track · Cerapedics, Inc.
Key facts
| Original PMA | P240001 |
|---|---|
| Supplement number | S001 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | PearlMatrix™ P-15 Peptide Enhanced Bone Graft (PearlMatrix™ Bone Graft) |
| Generic name | Filler, bone void, synthetic peptide |
| Applicant | Cerapedics, Inc. |
| Product code | NOX |
| Received date | Sep 8, 2025 |
| Decision date | Dec 11, 2025 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: