PMA
P030027: CERAMIC TRANSCEND HIP ARTICULATION
FDA PMA · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented · Microport Orthopedics, Inc.
Key facts
| PMA number | P030027 |
|---|---|
| Trade name | CERAMIC TRANSCEND HIP ARTICULATION |
| Generic name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
| Applicant | Microport Orthopedics, Inc. |
| Owner/operator | MicroPort Orthopedics Inc. |
| Product code | MRA |
| Approval date | Jul 7, 2003 |
| Docket number | 03M-0356 |
| Notice date | Aug 12, 2003 |
| Establishment registration | 3010536692 |
| FEI number | 3010536692 |
At a glance
- 1–9 Supplements
- Feb 16, 2018 Latest supplement decision
- No Withdrawn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: