PMA
P150030: R3 DELTA CERAMIC HIP SYSTEM
FDA PMA · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented · Smith & Nephew, Inc.
Key facts
| PMA number | P150030 |
|---|---|
| Trade name | R3 DELTA CERAMIC HIP SYSTEM |
| Generic name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
| Applicant | Smith & Nephew, Inc. |
| Owner/operator | Smith & Nephew, Inc. |
| Product code | MRA |
| Approval date | Oct 17, 2016 |
| Docket number | 16M-3430 |
| Notice date | Oct 20, 2016 |
| Establishment registration | 1020279 |
| FEI number | 1020279 |
At a glance
- 10–99 Supplements
- Apr 17, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: