PMA
P050004: EMS SWISS DOLORCLAST
FDA PMA · Generator, shock-wave, for pain relief · Electro Medical Systems (Ems Sa)
Key facts
| PMA number | P050004 |
|---|---|
| Trade name | EMS SWISS DOLORCLAST |
| Generic name | Generator, shock-wave, for pain relief |
| Applicant | Electro Medical Systems (Ems Sa) |
| Owner/operator | E.M.S. ELECTRO MEDICAL SYSTEMS S.A. |
| Product code | NBN |
| Approval date | May 8, 2007 |
| Docket number | 07M-0253 |
| Notice date | Jun 28, 2007 |
| Establishment registration | 3004096429 |
| FEI number | 3004096429 |
At a glance
- 1–9 Supplements
- Aug 28, 2009 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: