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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
landis and gyr strasse 1
zug CH-63-6300
PMA NumberP070009
Date Received04/02/2007
Decision Date09/28/2007
Product Code
LTI[ Registered Establishments with LTI ]
Docket Number 07M-0380
Notice Date 11/09/2007
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the realize adjustable gastric band. This device is indicated for weight reduction for morbidly obese patients and is indicated for individuals with a body mass index (bmi) of at least 40 kg/m2, or a bmi of at least 35 kg/m2 with one or more comorbid conditions. The band is indicated for use only in morbidly obese adult patients who have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs.
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 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017