PMA supplement
P030042 S004: CONSERVE PLUS TOTAL RESURFACING SYSTEM
FDA PMA supplement · Real-Time Process · Microport Orthopedics, Inc.
Key facts
| Original PMA | P030042 |
|---|---|
| Supplement number | S004 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | CONSERVE PLUS TOTAL RESURFACING SYSTEM |
| Generic name | Prosthesis, hip, semi-constrained, metal/metal, resurfacing |
| Applicant | Microport Orthopedics, Inc. |
| Product code | NXT |
| Received date | Aug 27, 2010 |
| Decision date | Aug 8, 2011 |
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: