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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received02/09/2000
Decision Date06/05/2001
Product Code
LTI[ Registered Establishments with LTI ]
Docket Number 02M-0250
Notice Date 06/03/2002
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? Yes
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the lap-band. Adjustable gastric banding (lagb. ) system. The device is indicated for use in weight reduction for severely obese patients with a body mass index (bmi) of at least 40 or a bmi of at least 35 with one or more severe comorbid conditions, or those who are 100 lbs. Or more over their estimated ideal weight according to the 1983 metropolitan life insurance tables (use the midpoint for medium frame). It is indicated for use only in severely obese 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
Supplements: S001 S002 S003 S004 S005 S006 S008 S009 S010 
S012 S013 S014 S017 S018 S019 S020 S021 S022 
S023 S024 S026 S027 S028 S029 S030 S031 S032 
S033 S034 S035 S036 S037