PMA
P860067: SALITRON SYSTEM
FDA PMA · Stimulator, salivary system · Biosonics, Inc.
Key facts
| PMA number | P860067 |
|---|---|
| Trade name | SALITRON SYSTEM |
| Generic name | Stimulator, salivary system |
| Applicant | Biosonics, Inc. |
| Owner/operator | DDS DENTALAB |
| Product code | LTF |
| Approval date | May 17, 1988 |
| Docket number | 88M-0205 |
| Notice date | Jul 14, 1988 |
| Establishment registration | 3006191485 |
| FEI number | 3006191485 |
At a glance
- None Supplements
- May 17, 1988 Latest supplement decision
- No Withdrawn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: