PMA
P870015: MEDSTONE 1050 ECTRACORPOREAL SHOCK WAVE LITHOTRIPT
FDA PMA · Lithotriptor, extracorporeal shock-wave, urological · Medstone Intl., Inc.
Key facts
| PMA number | P870015 |
|---|---|
| Trade name | MEDSTONE 1050 ECTRACORPOREAL SHOCK WAVE LITHOTRIPT |
| Generic name | Lithotriptor, extracorporeal shock-wave, urological |
| Applicant | Medstone Intl., Inc. |
| Owner/operator | RxSight Inc. |
| Product code | LNS |
| Approval date | Apr 15, 1988 |
| Docket number | 88M-0186 |
| Notice date | Jun 7, 1988 |
| Establishment registration | 3012712027 |
| FEI number | 3012712027 |
At a glance
- 10–99 Supplements
- Jul 26, 2000 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 10–99 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: