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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameREALIZE ADJUSTABLE GASTRIC BAND/REALIZE INJECTION PORT
Classification Nameimplant, intragastric for morbid obesity
ApplicantETHICON ENDO-SURGERY, INC.
PMA NumberP070009
Supplement NumberS002
Date Received03/13/2008
Decision Date04/09/2008
Product Code
LTI[ Registered Establishments with LTI ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes to the manufacturing method and assembly for the realize adjustable gastric band and realize injection port.
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