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Lap-Band Adjustable Gastric Banding System

by Medtimo, Inc.

PMA P000008

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

3 closed

Documents

PMA P000008↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP000008 Date5 Jun 2001ApprovedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-2743-2018 FDA Class II initiated 22 Nov 2017

    Component of the Lap-Band system was missing from the package

    • Terminated Z-2123-2011 FDA Unclassified (pre-2012) initiated 21 Mar 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 longer be sterile.

    • Terminated Z-0418-2011 FDA Unclassified (pre-2012) initiated 16 Sep 2010

    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 LAP-BAND to its widest, open position requiring a procedure to replace the port. The patient may have symptoms of reduced satiety and increased appetite. Stalling

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Full name
Lap-Band Adjustable Gastic Banding System
Trade Name
Lap-Band Adjustable Gastric Banding System
Generic Name
IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
PMA Number
FDA Product Code
LTI
Device Class
Class III
Advisory Committee
Gastroenterology, Urology
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Lap-Band Adjustable Gastric Banding System is an intragastric implant designed for weight reduction in severely obese adult patients. It is indicated for individuals with a body mass index of at least 40, or those with a BMI of at least 35 who have one or more severe comorbid conditions or are 100 lbs or more over their estimated ideal weight.

This system is intended for use only in patients who have failed more conservative weight-reduction alternatives, such as supervised diet, exercise, and behavior modification programs. Patients electing to undergo this surgery must commit to significant, lifelong changes in their eating habits. The device is authorized under FDA PMA P000008.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Who is a candidate for the Lap-Band Adjustable Gastric Banding System?

    Candidates must be severely obese adults who have failed conservative weight-reduction alternatives. Specifically, this includes patients with a BMI of at least 40, or a BMI of at least 35 with severe comorbid conditions, or those who are 100 lbs or more over their estimated ideal weight.

  • What is the primary purpose of this device?

    The device is an intragastric implant used for weight reduction in patients who meet specific clinical criteria for severe obesity and have not achieved success with diet, exercise, or behavior modification.

  • Does the Lap-Band system require lifestyle changes?

    Yes, patients who elect to have this surgery must make a commitment to accept significant changes in their eating habits for the rest of their lives to ensure the effectiveness of the treatment.