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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceLAP-BAND
Generic NameIMPLANT, INTRAGASTRIC FOR MORBID OBESITY
ApplicantReShape Lifesciences, Inc.
1001 Calle Amanecer
San Clemente, CA 92672
PMA NumberP000008
Supplement NumberS017
Date Received04/27/2010
Decision Date02/16/2011
Product Code LTI 
Docket Number 12M-1013
Notice Date 09/26/2012
Advisory Committee Gastroenterology/Urology
Clinical TrialsNCT00570505
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
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