PMA supplement
P060037 S005: NEXGEN COMPLETE KNEE SOLUTION
FDA PMA supplement · Normal 180 Day Track · Zimmer, Inc.
Key facts
| Original PMA | P060037 |
|---|---|
| Supplement number | S005 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | NEXGEN COMPLETE KNEE SOLUTION |
| Generic name | Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing |
| Applicant | Zimmer, Inc. |
| Product code | NJL |
| Received date | Sep 29, 2008 |
| Decision date | Mar 26, 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: