PMA supplement
P010039 S003: SONOCUR BASIC EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT)
FDA PMA supplement · Normal 180 Day Track No User Fee · Siemens Medical Solutions USA, Inc.
Key facts
| Original PMA | P010039 |
|---|---|
| Supplement number | S003 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol |
| Trade name | SONOCUR BASIC EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT) |
| Generic name | Generator, shock-wave, for pain relief |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Product code | NBN |
| Received date | Oct 28, 2004 |
| Decision date | Sep 27, 2005 |
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: