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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.
Classification Nameagent, bulking, injectable for gastro-urology use
Generic Nameinjectable bulking agent
PMA NumberP980053
Supplement NumberS002
Date Received01/09/2001
Decision Date01/23/2001
Product Code
LNM[ Registered Establishments with LNM ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of an alternate vendor, carbon coating technologies, to supply the pyloric carbon coated bead component of the durasphere injectable bulking agent(r).