PMA
P890013: RICHARD WOLF PIEZOLITH E.L.P. LITHOTRIPT MODEL2300
FDA PMA · Lithotriptor, extracorporeal shock-wave, urological · Richard Wolf Medical Instruments Corp.
Key facts
| PMA number | P890013 |
|---|---|
| Trade name | RICHARD WOLF PIEZOLITH E.L.P. LITHOTRIPT MODEL2300 |
| Generic name | Lithotriptor, extracorporeal shock-wave, urological |
| Applicant | Richard Wolf Medical Instruments Corp. |
| Owner/operator | RICHARD WOLF GMBH |
| Product code | LNS |
| Approval date | Sep 9, 1991 |
| Docket number | 91M-0368 |
| Notice date | Oct 10, 1991 |
| Establishment registration | 1418479 |
| FEI number | 1418479 |
At a glance
- None Supplements
- Sep 9, 1991 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- No Withdrawn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: