PMA supplement
P030022 S041: REFLECTION CERAMIC ACETABULAR SYSTEM
FDA PMA supplement · Special (Immediate Track) · Smith & Nephew, Inc.
Key facts
| Original PMA | P030022 |
|---|---|
| Supplement number | S041 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | REFLECTION CERAMIC ACETABULAR SYSTEM |
| Generic name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
| Applicant | Smith & Nephew, Inc. |
| Product code | MRA |
| Received date | Nov 23, 2016 |
| Decision date | Dec 8, 2016 |
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: