# P000008: Lap-Band Adjustable Gastric Banding System

- Pathway: PMA
- Applicant: Medtimo, Inc.
- Decided: Jun 5, 2001 after 482 days
- Product code: LTI (Implant, Intragastric For Morbid Obesity)
- Device class: 3
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Nov 22, 2017 · Class II · Z-2743-2018: Component of the Lap-Band system was missing from the package
- Mar 21, 2011 · Not classified · Z-2123-2011: 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 l
- Sep 16, 2010 · Not classified · Z-0418-2011: 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

Source page: https://510kreport.com/device/P000008
Methodology: https://510kreport.com/methodology