PMA
P080028: STORZ MEDICAL DUOLITH SD1 SHOCK WAVE THERAPY
FDA PMA · Generator, shock-wave, for pain relief · Storz Medical AG
Key facts
| PMA number | P080028 |
|---|---|
| Trade name | STORZ MEDICAL DUOLITH SD1 SHOCK WAVE THERAPY |
| Generic name | Generator, shock-wave, for pain relief |
| Applicant | Storz Medical AG |
| Owner/operator | STORZ MEDICAL AG |
| Product code | NBN |
| Approval date | Jan 8, 2016 |
| Docket number | 16M-0122 |
| Notice date | Jan 11, 2016 |
| Establishment registration | 9613347 |
| FEI number | 3002808188 |
At a glance
- 1–9 Supplements
- Feb 5, 2020 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- No Withdrawn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: