PMA
P970062: GENESTONE 190 LITHOTRIPTER
FDA PMA · Lithotriptor, extracorporeal shock-wave, urological · Bmt, Inc.
Key facts
| PMA number | P970062 |
|---|---|
| Trade name | GENESTONE 190 LITHOTRIPTER |
| Generic name | Lithotriptor, extracorporeal shock-wave, urological |
| Applicant | Bmt, Inc. |
| Owner/operator | DANY BMT Co., Ltd. |
| Product code | LNS |
| Approval date | Jun 24, 1998 |
| Docket number | 98M-0507 |
| Notice date | Oct 7, 1998 |
| Establishment registration | 3010206197 |
| FEI number | 3010206197 |
At a glance
- None Supplements
- Jun 24, 1998 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- No Withdrawn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: