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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.
 
DeviceORBERA INTRAGASTRIC BALLOON
Classification Nameimplant, intragastric for morbid obesity
Generic Nameimplant, intragastric for morbid obesity
Applicant
APOLLO ENDOSURGERY INC
1120 s capital of tx hwy
bldg 1, ste 300
austin, TX 78746-0000
PMA NumberP140008
Date Received04/29/2014
Decision Date08/05/2015
Product Code
LTI[ Registered Establishments with LTI ]
Docket Number 15M-2964
Notice Date 08/06/2015
Advisory Committee Gastroenterology/Urology
Clinical Trials NCT00730327
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE ORBERA INTRAGASTRIC BALLOON. THE ORBERA INTRAGASTRIC BALLOON SYSTEM IS INDICATED FOR USE AS AN ADJUNCT TO WEIGHT REDUCTION FOR ADULTS WITH OBESITY WITH BODY MASS INDEX (BMI) OF >= 30 AND <= 40 KG/M2 AND IS TO BE USED IN CONJUNCTION WITH A LONG-TERM SUPERVISED DIET AND BEHAVIOR MODIFICATION PROGRAM DESIGNED TO INCREASE THE POSSIBILITY OF SIGNIFICANT LONG-TERM WEIGHT LOSS AND MAINTENANCE OF THAT WEIGHT LOSS. ORBERA IS INDICATED FOR ADULT PATIENTS WHO HAVE FAILED MORE CONSERVATIVE WEIGHT REDUCTION ALTERNATIVES, SUCH AS SUPERVISED DIET, EXERCISE AND BEHAVIOR MODIFICATION PROGRAMS. THE MAXIMUM PLACEMENT PERIOD FOR ORBERA IS 6 MONTHS.
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 S005 S006 S007 
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