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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
Generic Nameinjectable gel
ApplicantSALIX PHARMACEUTICALS, INC.
PMA NumberP100014
Supplement NumberS012
Date Received11/26/2013
Decision Date05/12/2014
Product Code
LNM[ Registered Establishments with LNM ]
Advisory Committee Gastroenterology/Urology
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Introduction of in-house produced water for injection (wfi).
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