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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.
 
DeviceEthicon Endo-Surgery Curved Adjustable Gastric Band with Sutureless Port and Applier; Ethicon Endo-Surgery Gastric Band
Generic NameIMPLANT, INTRAGASTRIC FOR MORBID OBESITY
ApplicantObtech Medical GmbH
Landis And Gyr Strasse 1
Zug CH-6300
PMA NumberP070009
Supplement NumberS016
Date Received04/21/2016
Decision Date05/16/2016
Withdrawal Date03/17/2017
Product Code LTI 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the trade name changes from REALIZE Adjustable Gastric Band-C with Injection Port and Applier to Ethicon Endo-Surgery Curved Adjustable Gastric Band with Sutureless Port and Applier, and REALIZE Injection Port and Applier to Ethicon Endo-Surgery Gastric Band Sutureless Port and Applier.
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