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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-6300
PMA NumberP070009
Supplement NumberS011
Date Received01/18/2011
Decision Date07/15/2011
Withdrawal Date03/17/2017
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE REALIZE PRESSURE RECORDING SYSTEM, INDICATED TO RECORD AND DISPLAY FLUID PRESSURE VARIATIONS WITHIN A CLOSED SYSTEM BY CONVERTING MECHANICAL INPUTS TO ANALOG/DIGITAL ELECTRICAL SIGNALS.
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