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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
Generic NameIMPLANT, INTRAGASTRIC FOR MORBID OBESITY
ApplicantOBTECH MEDICAL GMBH
LANDIS AND GYR STRASSE 1
ZUG CH-63-6300
PMA NumberP070009
Supplement NumberS015
Date Received03/09/2015
Decision Date04/20/2015
Withdrawal Date 03/17/2017
Product Code LTI 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ADDITION OF A PACKAGE INSPECTION STEP FOR THE ETHICON ENDO-SURGERY CURVED ADJUSTABLE GASTRIC WITH SUTURELESS PORT AND APPLIER, AND THE ETHICON ENDO-SURGERY GASTRIC BAND SUTURELESS PORT AND APPLIER.
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