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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 BANDS WITH INJECTION PORT AND APPLIER
Generic NameIMPLANT, INTRAGASTRIC FOR MORBID OBESITY
ApplicantOBTECH MEDICAL GMBH
LANDIS AND GYR STRASSE 1
ZUG CH-63-6300
PMA NumberP070009
Supplement NumberS012
Date Received02/08/2011
Decision Date03/31/2011
Withdrawal Date 03/17/2017
Product Code LTI 
Advisory Committee Gastroenterology/Urology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE USE OF AN ALTERNATE SUPPLIER FOR THE INJECTION MOLDING OF THE SEPTUM AND CONNECTOR SLEEVE COMPONENTS OF THE INJECTION PORT.
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