PMA
P960054: S-ROM POLY-DIAL CONSTRAINED LINER
FDA PMA · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer · Depuy, A Johnson & Johnson Co.
Key facts
| PMA number | P960054 |
|---|---|
| Trade name | S-ROM POLY-DIAL CONSTRAINED LINER |
| Generic name | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer |
| Applicant | Depuy, A Johnson & Johnson Co. |
| Owner/operator | JOHNSON & JOHNSON MEDICAL CARIBBEAN |
| Product code | KWZ |
| Approval date | Jun 19, 1997 |
| Docket number | 97M-0416 |
| Notice date | Oct 7, 1997 |
| Establishment registration | 3005273611 |
| FEI number | 1000328785 |
At a glance
- 1–9 Supplements
- Dec 22, 1999 Latest supplement decision
- No Withdrawn
- No 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: