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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-C
Classification Nameimplant, intragastric for morbid obesity
ApplicantETHICON ENDO-SURGERY, INC.
PMA NumberP070009
Supplement NumberS006
Date Received09/08/2009
Decision Date10/06/2009
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 
Addition of an in-house manufacturing site for a device component as well as changes to several manufacturing steps.
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