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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 NumberS007
Date Received04/28/2009
Decision Date06/26/2009
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 modification of the spanner proximal tube assembly to replace the stainless steel coil with a high durometer silicone sleeve.