PMA
P870011: HMT SHOCK PLUG/LITHOTRIPTER ELECTRODE
FDA PMA · Lithotriptor, extracorporeal shock-wave, urological · Towers Perrin
Key facts
| PMA number | P870011 |
|---|---|
| Trade name | HMT SHOCK PLUG/LITHOTRIPTER ELECTRODE |
| Generic name | Lithotriptor, extracorporeal shock-wave, urological |
| Applicant | Towers Perrin |
| Product code | LNS |
| Approval date | Sep 6, 1990 |
| Docket number | 90m-0303 |
| Notice date | Oct 19, 1990 |
At a glance
- None Supplements
- Sep 6, 1990 Latest supplement decision
- No Withdrawn
- No 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: