PMA
P950043: ECONOLITH(TM) LITHOTRIPTER
FDA PMA · Lithotriptor, extracorporeal shock-wave, urological · Medispec, Ltd.
Key facts
| PMA number | P950043 |
|---|---|
| Trade name | ECONOLITH(TM) LITHOTRIPTER |
| Generic name | Lithotriptor, extracorporeal shock-wave, urological |
| Applicant | Medispec, Ltd. |
| Owner/operator | MEDISPEC, LTD. |
| Product code | LNS |
| Approval date | Apr 7, 1997 |
| Docket number | 97M-0253 |
| Notice date | Jul 10, 1997 |
| Establishment registration | 1123459 |
| FEI number | 1000136413 |
At a glance
- 1–9 Supplements
- Aug 27, 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- No Withdrawn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: