PMA supplement
P110015 S008: 13C-Spirulina Gastric Emptying Breath Test (GEBT)
FDA PMA supplement · Real-Time Process · Advanced Breath Diagnostics
Key facts
| Original PMA | P110015 |
|---|---|
| Supplement number | S008 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | 13C-Spirulina Gastric Emptying Breath Test (GEBT) |
| Generic name | Gastric Emptying Breath Test |
| Applicant | Advanced Breath Diagnostics |
| Product code | PGE |
| Received date | Mar 16, 2021 |
| Decision date | Aug 10, 2021 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: