PMA supplement
P060037 S048: NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM
FDA PMA supplement · 30-Day Notice · Zimmer, Inc.
Key facts
| Original PMA | P060037 |
|---|---|
| Supplement number | S048 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM |
| Generic name | Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing |
| Applicant | Zimmer, Inc. |
| Product code | NJL |
| Received date | Nov 23, 2016 |
| Decision date | Jan 12, 2017 |
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: