PMA supplement
P950043 S001: ECONOLITH(TM) LITHOTRIPTER
FDA PMA supplement · Real-Time Process · Medispec, Ltd.
Key facts
| Original PMA | P950043 |
|---|---|
| Supplement number | S001 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | ECONOLITH(TM) LITHOTRIPTER |
| Generic name | Lithotriptor, extracorporeal shock-wave, urological |
| Applicant | Medispec, Ltd. |
| Product code | LNS |
| Received date | Jun 25, 1997 |
| Decision date | Jun 30, 1997 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: