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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameimplant, intragastric for morbid obesity
Generic Nameimplant, intragastric for morbid obesity
1120 s capital of tx hwy
bldg 1, ste 300
austin, TX 78746
PMA NumberP000008
Supplement NumberS017
Date Received04/27/2010
Decision Date02/16/2011
Product Code
LTI[ Registered Establishments with LTI ]
Docket Number 12M-1013
Notice Date 09/26/2012
Advisory Committee Gastroenterology/Urology
Clinical Trials NCT00570505
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for lap-band adjustable gastric banding system. The lap-band system is indicated for weight reduction for patients with obesity, with a body mass index (bmi) of at least 40 kg/m2 or a bmi of at least 30 kg/ m2 with one or more obesity related comorbid conditions. It is indicated for use in adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise and behavior modification programs. Patients who elect to have this surgery must make the commitment to accept significant changes in their eating habits for the rest of their lives.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress