PMA supplement
P000008 S017: LAP-BAND
FDA PMA supplement · Panel Track · Medtimo, Inc.
Key facts
| Original PMA | P000008 |
|---|---|
| Supplement number | S017 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | LAP-BAND |
| Generic name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
| Applicant | Medtimo, Inc. |
| Product code | LTI |
| Received date | Apr 27, 2010 |
| Decision date | Feb 16, 2011 |
| Docket number | 12M-1013 |
| Notice date | Sep 26, 2012 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: