PMA supplement
P030022 S039: REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)
FDA PMA supplement · Normal 180 Day Track No User Fee · Smith & Nephew, Inc.
Key facts
| Original PMA | P030022 |
|---|---|
| Supplement number | S039 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - PAS |
| Trade name | REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS) |
| Generic name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
| Applicant | Smith & Nephew, Inc. |
| Product code | MRA |
| Received date | Sep 19, 2016 |
| Decision date | Mar 20, 2018 |
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: