PMA supplement
P910016 S007: NEW JERSEY LCS(R) UNICOMPARTMENTAL KNEE
FDA PMA supplement · Normal 180 Day Track · Depuy, Inc.
Key facts
| Original PMA | P910016 |
|---|---|
| Supplement number | S007 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | NEW JERSEY LCS(R) UNICOMPARTMENTAL KNEE |
| Generic name | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER |
| Applicant | Depuy, Inc. |
| Product code | MBD |
| Received date | May 25, 1995 |
| Decision date | Jan 2, 1996 |
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: