PMA · Approved
Recalled · Class II · 2017Lap-Band Adjustable Gastric Banding System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtimo, Inc. · LTI Implant, Intragastric For Morbid Obesity
Approved on Jun 5, 2001 through premarket approval, which rests on the device’s own clinical evidence after a 482-day review. It has been recalled 3 times.
- Decided
- Jun 5, 2001
- Review
- 482 days
- Class
- Class III
- Product code
- LTI
- Recalls
- 3
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P000008 has 46 supplements since 2002: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2002 | 4 |
| 2003 | 2 |
| 2006 | 2 |
| 2007 | 1 |
| 2008 | 2 |
| 2009 | 1 |
| 2010 | 3 |
| 2011 | 6 |
| 2012 | 1 |
| 2013 | 2 |
| 2014 | 3 |
| 2015 | 1 |
| 2016 | 4 |
| 2017 | 2 |
| 2018 | 5 |
| 2019 | 3 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 1 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LTI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 22, 2017 | Class II | Z-2743-2018 | Under Investigation by firm | Component of the Lap-Band system was missing from the package |
| Mar 21, 2011 | Not classified | Z-2123-2011 | Pending | The recall was initiated because Allergan has determined that a number of Access Port Needle pouches from one specific lot number may have small gaps in a pouch seal. Consequently the product may no longer be sterile. |
| Sep 16, 2010 | Not classified | Z-0418-2011 | Pending | In a LAP-BAND System adjustment, failure to inject the needle perpendicular to the access port septum, as described in Directions for Use, may lead to port damage, resulting in subsequent port leakage. Leakage results in deflation of the… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LTI devicesLTI Implant, Intragastric For Morbid Obesity: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LTI
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LTI
Too few LTI 510(k)s in any year since 2007 to give a median.
Recalls per year · LTI
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LTI
295in 2025
MAUDE reports naming product code LTI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 587 |
| 2008 | 5 | — | 0 | 1,357 |
| 2009 | 4 | — | 0 | 1,365 |
| 2010 | 7 | — | 17 | 1,461 |
| 2011 | 10 | — | 1 | 1,347 |
| 2012 | 1 | — | 0 | 1,383 |
| 2013 | 2 | — | 3 | 920 |
| 2014 | 3 | — | 0 | 563 |
| 2015 | 6 | — | 0 | 560 |
| 2016 | 14 | — | 1 | 514 |
| 2017 | 14 | — | 0 | 528 |
| 2018 | 32 | — | 0 | 453 |
| 2019 | 21 | — | 0 | 334 |
| 2020 | 5 | — | 0 | 165 |
| 2021 | 3 | — | 0 | 193 |
| 2022 | 2 | — | 0 | 609 |
| 2023 | 4 | — | 0 | 975 |
| 2024 | 4 | — | 0 | 451 |
| 2025 | 2 | — | 0 | 295 |
| 2026 | 4 | — | 0 | — |
https://510kreport.com/device/P000008 · printed Nov 6, 2026
Cite this page
510(k) Report. “P000008: Lap-Band Adjustable Gastric Banding System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P000008
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026