PMA supplement
P840008 S040: MODEL MFL5000 EXPANSION OF INDICATION RANGE
FDA PMA supplement · Panel Track · Dornier Medtech America, Inc.
Key facts
| Original PMA | P840008 |
|---|---|
| Supplement number | S040 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | MODEL MFL5000 EXPANSION OF INDICATION RANGE |
| Generic name | Lithotriptor, extracorporeal shock-wave, urological |
| Applicant | Dornier Medtech America, Inc. |
| Product code | LNS |
| Received date | May 11, 1992 |
| Decision date | Mar 8, 1993 |
| Docket number | 93M-0124 |
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: