PMA supplement
P000058 S096: Infuse Bone Graft
FDA PMA supplement · Panel Track · Medtronic Sofamor Danek USA, Inc.
Key facts
| Original PMA | P000058 |
|---|---|
| Supplement number | S096 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Infuse Bone Graft |
| Generic name | Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction |
| Applicant | Medtronic Sofamor Danek USA, Inc. |
| Product code | NEK |
| Received date | Aug 19, 2025 |
| Decision date | Feb 13, 2026 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: