PMA
P790016: SALIVART
FDA PMA · Saliva, artificial · Westport Pharmaceuticals, Inc.
Key facts
| PMA number | P790016 |
|---|---|
| Trade name | SALIVART |
| Generic name | Saliva, artificial |
| Applicant | Westport Pharmaceuticals, Inc. |
| Product code | LFD |
| Approval date | Sep 19, 1979 |
| Docket number | 80M-0058 |
| Notice date | Apr 25, 1980 |
At a glance
- None Supplements
- Sep 19, 1979 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- No Withdrawn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: