PMA
P890066: THERASONIC LITHOTRIPSY TREATMENT SYSTEM
FDA PMA · Lithotriptor, extracorporeal shock-wave, urological · Focus Surgery, Inc.
Key facts
| PMA number | P890066 |
|---|---|
| Trade name | THERASONIC LITHOTRIPSY TREATMENT SYSTEM |
| Generic name | Lithotriptor, extracorporeal shock-wave, urological |
| Applicant | Focus Surgery, Inc. |
| Owner/operator | Sonablate Corp. (FKA) SonaCare Medical, LLC |
| Product code | LNS |
| Approval date | Dec 20, 1991 |
| Establishment registration | 2951226 |
| FEI number | 3002132857 |
At a glance
- 1–9 Supplements
- Apr 18, 1994 Latest supplement decision
- Yes Withdrawn
- No 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: