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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 & APPLIER
Generic NameIMPLANT, INTRAGASTRIC FOR MORBID OBESITY
ApplicantOBTECH MEDICAL GMBH
LANDIS AND GYR STRASSE 1
ZUG CH-63-6300
PMA NumberP070009
Supplement NumberS013
Date Received02/08/2011
Decision Date03/31/2011
Withdrawal Date 03/17/2017
Product Code LTI 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A DEVICE CHANGE TO MODIFY THE SILICONE MATERIAL USED FOR THE INJECTION PORT SEPTUM AND INJECTION PORT CONNECTOR SLEEVE COMPONENTS, ALONG WITH A MINOR ASSOCIATED LABELING MODIFICATION.
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