PMA
P050053: INFUSE BONE GRAFT
FDA PMA · Bone grafting material, dental, with biologic component · Medtronic, Inc.
Key facts
| PMA number | P050053 |
|---|---|
| Trade name | INFUSE BONE GRAFT |
| Generic name | Bone grafting material, dental, with biologic component |
| Applicant | Medtronic, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | NPZ |
| Approval date | Mar 9, 2007 |
| Docket number | 07M-0084 |
| Notice date | Mar 13, 2007 |
| 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- No Withdrawn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: