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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 NameTEGRESS URETHRAL IMPLANT
Classification Nameagent, bulking, injectable for gastro-urology use
Generic Nameinjectable bulking agent
ApplicantC.R. BARD, INC.
PMA NumberP030030
Supplement NumberS001
Date Received01/28/2005
Decision Date02/09/2005
Product Code
LNM[ Registered Establishments with LNM ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification of the labeling to reflect a new device trade name. The device, as modified, will be marketed under the trade name tegress urethral implant and is indicated for transurethral injection in the treatment of adult women diagnosed with stress urinary incontinence (sui) due to intrinsic sphincter deficiency (isd).
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