PMA
P040039: ORBASONE PAIN RELIEF SYSTEM
FDA PMA · Generator, shock-wave, for pain relief · Orthometrix, Inc.
Key facts
| PMA number | P040039 |
|---|---|
| Trade name | ORBASONE PAIN RELIEF SYSTEM |
| Generic name | Generator, shock-wave, for pain relief |
| Applicant | Orthometrix, Inc. |
| Product code | NBN |
| Approval date | Aug 10, 2005 |
| Docket number | 05M-0339 |
| Notice date | Aug 25, 2005 |
| FEI number | 1000610068 |
At a glance
- None Supplements
- Aug 10, 2005 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- Yes Withdrawn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: