PMA
P920051: STORZ MODULITH (TM) LITHOTRIPTER
FDA PMA · Lithotriptor, extracorporeal shock-wave, urological · KARL STORZ Endoscopy-America, Inc.
Key facts
| PMA number | P920051 |
|---|---|
| Trade name | STORZ MODULITH (TM) LITHOTRIPTER |
| Generic name | Lithotriptor, extracorporeal shock-wave, urological |
| Applicant | KARL STORZ Endoscopy-America, Inc. |
| Owner/operator | KARL STORZ SE & CO KG |
| Product code | LNS |
| Approval date | Feb 17, 1995 |
| Docket number | 95m-0396 |
| Notice date | Dec 15, 1995 |
| Establishment registration | 2020550 |
| FEI number | 2020550 |
At a glance
- 1–9 Supplements
- Oct 31, 1997 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- No Withdrawn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: