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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceREALIZE ADJUSTABLE GASTRIC BAND MODEL 2200-X
Generic NameIMPLANT, INTRAGASTRIC FOR MORBID OBESITY
ApplicantOBTECH MEDICAL GMBH
LANDIS AND GYR STRASSE 1
ZUG CH-63-6300
PMA NumberP070009
Date Received04/02/2007
Decision Date09/28/2007
Withdrawal Date 03/17/2017
Product Code LTI 
Docket Number 07M-0380
Notice Date 11/09/2007
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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 
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