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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 NameSOLESTA
Classification Nameagent, bulking, injectable for gastro-urology use
ApplicantSALIX PHARMACEUTICALS, INC.
PMA NumberP100014
Supplement NumberS009
Date Received04/04/2013
Decision Date01/14/2014
Product Code
LNM[ Registered Establishments with LNM ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling for post approval study
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the revision of the prescribing information to include 24 and 26 month data.
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