PMA
P110015: GASTRIC EMPTYING BREATH TEST (GEBT)
FDA PMA · Gastric Emptying Breath Test · Advanced Breath Diagnostics
Key facts
| PMA number | P110015 |
|---|---|
| Trade name | GASTRIC EMPTYING BREATH TEST (GEBT) |
| Generic name | Gastric Emptying Breath Test |
| Applicant | Advanced Breath Diagnostics |
| Owner/operator | Advanced Breath Diagnostics, LLC |
| Product code | PGE |
| Approval date | Apr 6, 2015 |
| Docket number | 15M-1178 |
| Notice date | Apr 14, 2015 |
| Establishment registration | 3010031043 |
| FEI number | 3009091796 |
At a glance
- 10–99 Supplements
- Apr 24, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: