PMA
P030042: CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM
FDA PMA · Prosthesis, hip, semi-constrained, metal/metal, resurfacing · Microport Orthopedics, Inc.
Key facts
| PMA number | P030042 |
|---|---|
| Trade name | CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM |
| Generic name | Prosthesis, hip, semi-constrained, metal/metal, resurfacing |
| Applicant | Microport Orthopedics, Inc. |
| Owner/operator | MicroPort Orthopedics Inc. |
| Product code | NXT |
| Approval date | Nov 3, 2009 |
| Docket number | 09M-0540 |
| Notice date | Nov 18, 2009 |
| Establishment registration | 3010536692 |
| FEI number | 3010536692 |
At a glance
- 1–9 Supplements
- Aug 8, 2011 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: