PMA supplement
P070026 S004: DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM
FDA PMA supplement · Panel Track · DePuy Orthopaedics, Inc.
Key facts
| Original PMA | P070026 |
|---|---|
| Supplement number | S004 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM |
| Generic name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
| Applicant | DePuy Orthopaedics, Inc. |
| Product code | MRA |
| Received date | Nov 1, 2011 |
| Decision date | Apr 2, 2013 |
| Docket number | 13M-0462 |
| Notice date | Apr 24, 2013 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: