PMA
P960001: DEPUY 1 BONE CEMENT
FDA PMA · BONE CEMENT · Depuy, Inc.
Key facts
| PMA number | P960001 |
|---|---|
| Trade name | DEPUY 1 BONE CEMENT |
| Generic name | BONE CEMENT |
| Applicant | Depuy, Inc. |
| Owner/operator | DePuy Synthes, Inc. |
| Product code | LOD |
| Approval date | Feb 11, 1997 |
| Docket number | 97M-0255 |
| Notice date | Jul 2, 1997 |
| Establishment registration | 8010379 |
| FEI number | 1000199976 |
At a glance
- 1–9 Supplements
- Sep 20, 1999 Latest supplement decision
- No Withdrawn
- No 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: