PMA
P040026: ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY DEVICE
FDA PMA · Generator, shock-wave, for pain relief · Medispec, Ltd.
Key facts
| PMA number | P040026 |
|---|---|
| Trade name | ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY DEVICE |
| Generic name | Generator, shock-wave, for pain relief |
| Applicant | Medispec, Ltd. |
| Owner/operator | MEDISPEC, LTD. |
| Product code | NBN |
| Approval date | Apr 1, 2005 |
| Docket number | 05M-0241 |
| Notice date | Jun 20, 2005 |
| Establishment registration | 1123459 |
| FEI number | 1000136413 |
At a glance
- None Supplements
- Apr 1, 2005 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: