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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 NameDURASPHERE EXP
Classification Nameagent, bulking, injectable for gastro-urology use
Generic Nameinjectable bulking agent
ApplicantCARBON MEDICAL TECHNOLOGIES, INC.
PMA NumberP980053
Supplement NumberS006
Date Received03/07/2003
Decision Date08/26/2003
Product Code
LNM[ Registered Establishments with LNM ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modified bead specification (90-212 um) for the pyrolytic carbon coated zirconium oxide and graphite beads. The device, as modified, will be marketed under the trade name durasphere exp and is indicated for use in the treatment of adult women with stress urinary incontinence (sui) due to intrinsic sphincter deficiency (isd).
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