PMA
P970042: MEDSTONE STS LITHOTRIPTER
FDA PMA · Lithotripter, shockwave (for treating gallbladder stones) · Medstone Intl., Inc.
Key facts
| PMA number | P970042 |
|---|---|
| Trade name | MEDSTONE STS LITHOTRIPTER |
| Generic name | Lithotripter, shockwave (for treating gallbladder stones) |
| Applicant | Medstone Intl., Inc. |
| Owner/operator | RxSight Inc. |
| Product code | NCV |
| Approval date | Sep 5, 2000 |
| Docket number | 00M-1515 |
| Notice date | Sep 15, 2000 |
| Establishment registration | 3012712027 |
| FEI number | 3012712027 |
At a glance
- 1–9 Supplements
- Feb 14, 2003 Latest supplement decision
- Yes Withdrawn
- Yes 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: