PMA
P000054: INFUSE BONE GRAFT
FDA PMA · Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction · Medtronic Sofamor Danek USA, Inc.
Key facts
| PMA number | P000054 |
|---|---|
| Trade name | INFUSE BONE GRAFT |
| Generic name | Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction |
| Applicant | Medtronic Sofamor Danek USA, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | MPW |
| Approval date | Apr 30, 2004 |
| Docket number | 04M-0249 |
| Notice date | May 26, 2004 |
| Establishment registration | 1030489 |
| FEI number | 1000477302 |
At a glance
- 10–99 Supplements
- Aug 26, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: