PMA
P970019: HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM
FDA PMA · Lithotriptor, extracorporeal shock-wave, urological · Healthtronics Surgical Services, Inc.
Key facts
| PMA number | P970019 |
|---|---|
| Trade name | HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM |
| Generic name | Lithotriptor, extracorporeal shock-wave, urological |
| Applicant | Healthtronics Surgical Services, Inc. |
| Owner/operator | BRIJ Medical, Inc. |
| Product code | LNS |
| Approval date | Jul 21, 1997 |
| Docket number | 97M-0453 |
| Notice date | Nov 14, 1997 |
| Establishment registration | 3017168759 |
| FEI number | 3017168759 |
At a glance
- 1–9 Supplements
- Dec 17, 1999 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- No Withdrawn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: