PMA
P960031: PERIOGARD PERIODONTAL TISSUE MONITOR
FDA PMA · Xytronyx, Inc.
Key facts
| PMA number | P960031 |
|---|---|
| Trade name | PERIOGARD PERIODONTAL TISSUE MONITOR |
| Applicant | Xytronyx, Inc. |
| Approval date | Jun 23, 1997 |
| Docket number | 98M-0036 |
| Notice date | Jan 27, 1998 |
At a glance
- 1–9 Supplements
- Sep 30, 1997 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- Yes Withdrawn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: