PMA supplement
P830055 S112: LCS TOTAL KNEE SYSTEM ¿ P.F.C. SIGMA RPF FEMORAL COMPONENTS
FDA PMA supplement · Special (Immediate Track) · Depuy, Inc.
Key facts
| Original PMA | P830055 |
|---|---|
| Supplement number | S112 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | LCS TOTAL KNEE SYSTEM ¿ P.F.C. SIGMA RPF FEMORAL COMPONENTS |
| Generic name | Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing |
| Applicant | Depuy, Inc. |
| Product code | NJL |
| Received date | Oct 6, 2009 |
| Decision date | Dec 8, 2009 |
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: