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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceDEFLUX INJECTABLE GEL
Generic NameAGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
ApplicantPalette Life Sciences
27 E Cota St.
Suite 402
Santa Barbara, CA 93101
PMA NumberP000029
Supplement NumberS017
Date Received03/06/2006
Decision Date03/28/2008
Product Code LNM 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT Q-MED AB, UPPSALA, SWEDEN, TO TEST FOR HEAVY METALS AND ANALYSIS OF NITRATES.
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