PMA supplement
P910016 S015: LCS UNI KNEE SYSTEM
FDA PMA supplement · Special (Immediate Track) · Depuy, Inc.
Key facts
| Original PMA | P910016 |
|---|---|
| Supplement number | S015 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | LCS UNI KNEE SYSTEM |
| Generic name | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER |
| Applicant | Depuy, Inc. |
| Product code | MBD |
| Received date | Nov 10, 2005 |
| Decision date | Dec 12, 2005 |
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: