PMA
P000048: DORNIER EPOS ULTRA
FDA PMA · Generator, shock-wave, for pain relief · Dornier Medtech America, Inc.
Key facts
| PMA number | P000048 |
|---|---|
| Trade name | DORNIER EPOS ULTRA |
| Generic name | Generator, shock-wave, for pain relief |
| Applicant | Dornier Medtech America, Inc. |
| Owner/operator | Dornier MedTech America, Inc. |
| Product code | NBN |
| Approval date | Jan 15, 2002 |
| Docket number | 02M-0034 |
| Notice date | Jan 25, 2002 |
| Establishment registration | 1037955 |
| FEI number | 1037955 |
At a glance
- None Supplements
- Jan 15, 2002 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- Yes Withdrawn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: