PMA
P840008: DORNIER LITHOTRIPTER COMPACT TRANSPORTABLE (DLCT)
FDA PMA · Lithotriptor, extracorporeal shock-wave, urological · Dornier Medtech America, Inc.
Key facts
| PMA number | P840008 |
|---|---|
| Trade name | DORNIER LITHOTRIPTER COMPACT TRANSPORTABLE (DLCT) |
| Generic name | Lithotriptor, extracorporeal shock-wave, urological |
| Applicant | Dornier Medtech America, Inc. |
| Owner/operator | Dornier MedTech America, Inc. |
| Product code | LNS |
| Approval date | Dec 19, 1984 |
| Docket number | 84M-0438 |
| Notice date | Jan 16, 1985 |
| Establishment registration | 1037955 |
| FEI number | 1037955 |
At a glance
- 10–99 Supplements
- Sep 2, 1999 Latest supplement decision
- No Withdrawn
- No 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: