PMA supplement
P840025 S001: GARREN GASTRIC BUBBLE
FDA PMA supplement · American Edwards Laboratories
Key facts
| Original PMA | P840025 |
|---|---|
| Supplement number | S001 |
| Trade name | GARREN GASTRIC BUBBLE |
| Generic name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
| Applicant | American Edwards Laboratories |
| Product code | LTI |
| Received date | Oct 28, 1985 |
| Decision date | Dec 18, 1985 |
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: