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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.
 
DeviceREALIZE ADJUSTABLE GASTRIC BAND
Generic NameIMPLANT, INTRAGASTRIC FOR MORBID OBESITY
ApplicantOBTECH MEDICAL GMBH
LANDIS AND GYR STRASSE 1
ZUG CH-63-6300
PMA NumberP070009
Supplement NumberS003
Date Received04/18/2008
Decision Date10/15/2008
Withdrawal Date 03/17/2017
Product Code LTI 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A LINE EXTENSION TO THE REALIZE ADJUSTABLE GASTRIC BANDTHE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME REALIZE ADJUSTABLE GASTRICBAND CURVED (MODEL BD3XV) AND IS INDICATED FOR WEIGHT REDUCTION FOR MORBIDLY OBESE PATIENTSAND IS INDICATED FOR INDIVIDUALS WITH A BODY MASS INDEX (BMI) OF AT LEAST 40 KG/M2, OR A BMI OFAT LEAST 35 KG/M2 WITH ONE OR MORE COMORBID CONDITIONS. THE BAND IS INDICATED FOR USE ONLY INMORBIDLY OBESE ADULT PATIENTS WHO HAVE FAILED MORE CONSERVATIVE WEIGHT-REDUCTION ALTERNATIVES,SUCH AS SUPERVISED DIET, EXERCISE AND BEHAVIOR MODIFICATION PROGRAMS.
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