PMA
P880011: TECHNOMED INTERNATIONAL SONOLITH 2000
FDA PMA · Lithotriptor, extracorporeal shock-wave, urological · Edap International Corp.
Key facts
| PMA number | P880011 |
|---|---|
| Trade name | TECHNOMED INTERNATIONAL SONOLITH 2000 |
| Generic name | Lithotriptor, extracorporeal shock-wave, urological |
| Applicant | Edap International Corp. |
| Owner/operator | EDAP Technomed Inc. |
| Product code | LNS |
| Approval date | Jun 23, 1989 |
| Docket number | 89M-0211 |
| Notice date | Jul 19, 1989 |
| Establishment registration | 1287394 |
| FEI number | 1287394 |
At a glance
- 1–9 Supplements
- Nov 6, 1997 Latest supplement decision
- No Withdrawn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: