PMA
P830035: GK-101E CARIES REMOVAL AGENT/SYSTEM
FDA PMA · SOLUTION, REMOVAL, CARRIES · Indevus Pharmaceuticals, Inc.
Key facts
| PMA number | P830035 |
|---|---|
| Trade name | GK-101E CARIES REMOVAL AGENT/SYSTEM |
| Generic name | SOLUTION, REMOVAL, CARRIES |
| Applicant | Indevus Pharmaceuticals, Inc. |
| Owner/operator | Endo USA |
| Product code | LMW |
| Approval date | Jul 6, 1984 |
| Docket number | 84M-0248 |
| Notice date | May 2, 1986 |
| Establishment registration | 2243842 |
| FEI number | 2243842 |
At a glance
- 1–9 Supplements
- Nov 25, 1987 Latest supplement decision
- Yes Withdrawn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: