PMA supplement
P960054 S002: S-ROM POLY-DIAL CONSTRAINED ACETABULAR LINER
FDA PMA supplement · Normal 180 Day Track · Depuy, A Johnson & Johnson Co.
Key facts
| Original PMA | P960054 |
|---|---|
| Supplement number | S002 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | S-ROM POLY-DIAL CONSTRAINED ACETABULAR LINER |
| Generic name | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer |
| Applicant | Depuy, A Johnson & Johnson Co. |
| Product code | KWZ |
| Received date | Jul 30, 1999 |
| Decision date | Dec 7, 1999 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: