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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.
 
DeviceLAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
Generic NameIMPLANT, INTRAGASTRIC FOR MORBID OBESITY
ApplicantReShape Lifesciences, Inc.
1001 Calle Amanecer
San Clemente, CA 92672
PMA NumberP000008
Date Received02/09/2000
Decision Date06/05/2001
Product Code LTI 
Docket Number 02M-0250
Notice Date 06/03/2002
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? Yes
Combination ProductNo
RecallsCDRH 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S024 S026  S022 S023 S031 S035 S010 S014 S021 S017 S018 
S019 S001 S002 S003 S004 S006 S009 S036 S032 S034 S033 S029 
S028 S027 S030 S005 S008 S020 S012 S013 S037 S039 S038 S047 
S040 S041 S042 S043 S044 S045 S046 S048 S049 
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