PMA supplement
P830035 S001: GK-101E CARIES REMOVAL AGENT/SYSTEM
FDA PMA supplement · Indevus Pharmaceuticals, Inc.
Key facts
| Original PMA | P830035 |
|---|---|
| Supplement number | S001 |
| Trade name | GK-101E CARIES REMOVAL AGENT/SYSTEM |
| Generic name | SOLUTION, REMOVAL, CARRIES |
| Applicant | Indevus Pharmaceuticals, Inc. |
| Product code | LMW |
| Received date | Oct 1, 1984 |
| Decision date | Apr 18, 1985 |
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: