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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 NumberS005
Date Received03/20/2012
Decision Date04/24/2012
Product Code
LNM[ Registered Establishments with LNM ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study protocol.
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