PMA
P010039: SIEMENS SONOCUR BASIC SYSTEM
FDA PMA · Generator, shock-wave, for pain relief · Siemens Medical Solutions USA, Inc.
Key facts
| PMA number | P010039 |
|---|---|
| Trade name | SIEMENS SONOCUR BASIC SYSTEM |
| Generic name | Generator, shock-wave, for pain relief |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Owner/operator | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Product code | NBN |
| Approval date | Jul 19, 2002 |
| Docket number | 01M-0336 |
| Notice date | Aug 6, 2002 |
| Establishment registration | 2240869 |
| FEI number | 2240869 |
At a glance
- 1–9 Supplements
- Sep 27, 2005 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: