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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 Namestent, urethral, prostatic, semi-permanent
Generic Namestent, urethral, prostatic, semi-permanent
76 treble cove road, #3
north billerica, MA 01862
PMA NumberP060010
Supplement NumberS008
Date Received10/16/2009
Decision Date12/09/2009
Product Code
NZC[ Registered Establishments with NZC ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the design of the distal anchor including molding the anchor flat, replacing the wire reinforcement with an increase in durometer of the silicone, and adding titanium dioxide as a white colorant.