PMA supplement
P050039 S007: EXATECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM
FDA PMA supplement · 135 Review Track For 30-Day Notice · Exactech, Inc.
Key facts
| Original PMA | P050039 |
|---|---|
| Supplement number | S007 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | EXATECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM |
| Generic name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
| Applicant | Exactech, Inc. |
| Product code | MRA |
| Received date | Oct 7, 2011 |
| Decision date | Apr 27, 2012 |
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: