PMA
P880042: EDAP LT.01 SHOCK WAVE LITHOTRIPTER
FDA PMA · Lithotriptor, extracorporeal shock-wave, urological · Edap International Corp.
Key facts
| PMA number | P880042 |
|---|---|
| Trade name | EDAP LT.01 SHOCK WAVE LITHOTRIPTER |
| Generic name | Lithotriptor, extracorporeal shock-wave, urological |
| Applicant | Edap International Corp. |
| Owner/operator | EDAP Technomed Inc. |
| Product code | LNS |
| Approval date | Dec 12, 1991 |
| Docket number | 91M-0507 |
| Notice date | Jan 15, 1992 |
| Establishment registration | 1287394 |
| FEI number | 1287394 |
At a glance
- 1–9 Supplements
- Dec 18, 1996 Latest supplement decision
- Yes Withdrawn
- No 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: