PMA supplement
P140019 S004: i-FACTOR Peptide Enhanced Bone Graft
FDA PMA supplement · Normal 180 Day Track No User Fee · Cerapedics, LLC
Key facts
| Original PMA | P140019 |
|---|---|
| Supplement number | S004 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - PAS |
| Trade name | i-FACTOR Peptide Enhanced Bone Graft |
| Generic name | Filler, bone void, synthetic peptide |
| Applicant | Cerapedics, LLC |
| Product code | NOX |
| Received date | Jun 15, 2020 |
| Decision date | Jul 22, 2020 |
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: