PMA
P870018: LITHOSTAR
FDA PMA · Lithotriptor, extracorporeal shock-wave, urological · Siemens Corp.
Key facts
| PMA number | P870018 |
|---|---|
| Trade name | LITHOSTAR |
| Generic name | Lithotriptor, extracorporeal shock-wave, urological |
| Applicant | Siemens Corp. |
| Owner/operator | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Product code | LNS |
| Approval date | Sep 30, 1988 |
| Docket number | 88M-0363 |
| Notice date | Nov 30, 1988 |
| Establishment registration | 2531814 |
| FEI number | 3002626007 |
At a glance
- 10–99 Supplements
- Jul 17, 2000 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- No Withdrawn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: