PMA supplement
P040013 S025: GEM 21S Growth Factor Enhanced Matrix
FDA PMA supplement · Real-Time Process · Lynch Biologics, LLC
Key facts
| Original PMA | P040013 |
|---|---|
| Supplement number | S025 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | GEM 21S Growth Factor Enhanced Matrix |
| Generic name | Bone grafting material, dental, with biologic component |
| Applicant | Lynch Biologics, LLC |
| Product code | NPZ |
| Received date | Nov 27, 2020 |
| Decision date | Jan 15, 2021 |
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: