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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.
 
DeviceRESHAPE INTEGRATED DUAL BALLOON SYSTEM
Classification Nameimplant, intragastric for morbid obesity
Generic Nameimplant, intragastric for morbid obesity
Applicant
RESHAPE MEDICAL, INC.
1001 calle iglesia
san clemente, CA 92673
PMA NumberP140012
Date Received07/01/2014
Decision Date07/28/2015
Product Code
LTI[ Registered Establishments with LTI ]
Docket Number 15M-2740
Notice Date 07/29/2015
Advisory Committee Gastroenterology/Urology
Clinical Trials NCT01061385
NCT01673698
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE RESHAPE INTEGRATED DUAL BALLOON SYSTEM. THE RESHAPE INTEGRATED DUAL BALLOON SYSTEM IS INDICATED FOR WEIGHT REDUCTION WHEN USED IN CONJUNCTION WITH DIET AND EXERCISE, IN OBESE PATIENTS WITH A BODY MASS INDEX (BMI) OF 30 40 KG/M2 AND ONE OR MORE OBESITY-RELATED COMORBID CONDITIONS. IT IS INDICATED FOR USE IN ADULT PATIENTS WHO HAVE FAILED WEIGHT REDUCTION WITH DIET AND EXERCISE ALONE.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 
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