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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 WITH INJECTION PORT & APPLIER
Classification Nameimplant, intragastric for morbid obesity
ApplicantETHICON ENDO-SURGERY, INC.
PMA NumberP070009
Supplement NumberS009
Date Received05/07/2010
Decision Date06/04/2010
Product Code
LTI[ Registered Establishments with LTI ]
Advisory Committee Gastroenterology/Urology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor changes to the labeling.
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