PMA supplement
P970042 S004: MEDSTONE STS LITHOTRIPTER FOR THE TREATMENT OF SYMPTOMATIC, SOLITARY, RADIOLUCENT, NON-CALCIFIED GALLSTONES
FDA PMA supplement · Normal 180 Day Track · Medstone Intl., Inc.
Key facts
| Original PMA | P970042 |
|---|---|
| Supplement number | S004 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Postapproval Study Protocol |
| Trade name | MEDSTONE STS LITHOTRIPTER FOR THE TREATMENT OF SYMPTOMATIC, SOLITARY, RADIOLUCENT, NON-CALCIFIED GALLSTONES |
| Generic name | Lithotripter, shockwave (for treating gallbladder stones) |
| Applicant | Medstone Intl., Inc. |
| Product code | NCV |
| Received date | Aug 2, 2002 |
| Decision date | Jan 28, 2003 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: