PMA supplement
P000008 S039: Lap-Band Adjustable Gastric Banding System
FDA PMA supplement · Normal 180 Day Track No User Fee · Medtimo, Inc.
Key facts
| Original PMA | P000008 |
|---|---|
| Supplement number | S039 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - PAS |
| Trade name | Lap-Band Adjustable Gastric Banding System |
| Generic name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
| Applicant | Medtimo, Inc. |
| Product code | LTI |
| Received date | Jul 5, 2017 |
| Decision date | Oct 2, 2017 |
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: