PMA supplement
P840008 S035: DORNIER MODELS MFL5000 MOBILE LITHOTRIPTER
FDA PMA supplement · Normal 180 Day Track · Dornier Medtech America, Inc.
Key facts
| Original PMA | P840008 |
|---|---|
| Supplement number | S035 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | DORNIER MODELS MFL5000 MOBILE LITHOTRIPTER |
| Generic name | Lithotriptor, extracorporeal shock-wave, urological |
| Applicant | Dornier Medtech America, Inc. |
| Product code | LNS |
| Received date | Oct 8, 1991 |
| Decision date | Jan 2, 1992 |
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: