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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/REALIZE ADJUSTABLE GASTRIC BAND-C
Classification Nameimplant, intragastric for morbid obesity
ApplicantETHICON ENDO-SURGERY, INC.
PMA NumberP070009
Supplement NumberS008
Date Received06/09/2010
Decision Date07/30/2010
Product Code
LTI[ Registered Establishments with LTI ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a device change to add a silicone adhesive to bond the strain relief sleeve and the locking connector components of the injection port.
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