PMA supplement
P040023 S011: DURALOC OPTION CERAMIC HIP SYSTEM
FDA PMA supplement · 135 Review Track For 30-Day Notice · DePuy Orthopaedics, Inc.
Key facts
| Original PMA | P040023 |
|---|---|
| Supplement number | S011 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | DURALOC OPTION CERAMIC HIP SYSTEM |
| Generic name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
| Applicant | DePuy Orthopaedics, Inc. |
| Product code | MRA |
| Received date | Aug 19, 2008 |
| Decision date | Mar 4, 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: