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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 WITH SUTURELESS PORT AND APPLIER; ETHICON ENDO-SURGERY GASTRIC BAND SUTUR
Generic NameIMPLANT, INTRAGASTRIC FOR MORBID OBESITY
ApplicantObtech Medical GmbH
Landis And Gyr Strasse 1
Zug CH-6300
PMA NumberP070009
Supplement NumberS017
Date Received06/21/2016
Decision Date10/11/2016
Withdrawal Date03/17/2017
Product Code LTI 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changes to the device labeling made as a result of the approval of the 5 year Post-Approval Study.
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