Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 NameDEFLUX INJECTABLE GEL
Classification Nameagent, bulking, injectable for gastro-urology use
Generic Nameinjectable bulking agent
ApplicantQ-MED AB
PMA NumberP000029
Supplement NumberS003
Date Received12/03/2002
Decision Date12/13/2002
Product Code
LNM[ Registered Establishments with LNM ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an increase in the labeled storage temperature to 25 degrees c and an expiration date of 18 months after manufacture.
-
-