PMA
P090002: PINNACLE COMPLETE ACETABULAR HIP SYSTEM
FDA PMA · Prosthesis, hip, semi-constrained, ceramic-on-metal articulation · DePuy Orthopaedics, Inc.
Key facts
| PMA number | P090002 |
|---|---|
| Trade name | PINNACLE COMPLETE ACETABULAR HIP SYSTEM |
| Generic name | Prosthesis, hip, semi-constrained, ceramic-on-metal articulation |
| Applicant | DePuy Orthopaedics, Inc. |
| Owner/operator | DePuy Synthes, Inc. |
| Product code | OVO |
| Approval date | Jun 13, 2011 |
| Docket number | 11M-0470 |
| Notice date | Jun 15, 2011 |
| Establishment registration | 1818910 |
| FEI number | 1818910 |
At a glance
- 1–9 Supplements
- Aug 6, 2013 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: