PMA supplement
P050016 S011: CORMET HIP RESURFACING SYSTEM
FDA PMA supplement · Normal 180 Day Track No User Fee · Corin USA
Key facts
| Original PMA | P050016 |
|---|---|
| Supplement number | S011 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - PAS |
| Trade name | CORMET HIP RESURFACING SYSTEM |
| Generic name | Prosthesis, hip, semi-constrained, metal/metal, resurfacing |
| Applicant | Corin USA |
| Product code | NXT |
| Received date | Jul 6, 2016 |
| Decision date | Dec 21, 2016 |
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: