PMA supplement
P010001 S010: TRANSCEND HIP ARTICULATION SYSTEM
FDA PMA supplement · 135 Review Track For 30-Day Notice · Ceramtec GmbH
Key facts
| Original PMA | P010001 |
|---|---|
| Supplement number | S010 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | TRANSCEND HIP ARTICULATION SYSTEM |
| Generic name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
| Applicant | Ceramtec GmbH |
| Product code | MRA |
| Received date | Jun 10, 2011 |
| Decision date | Feb 14, 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: