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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, permanent or semi-permanent
Generic Nameurethral stent
PMA NumberP920023
Supplement NumberS004
Date Received06/22/1998
Decision Date07/15/1998
Product Code
MER[ Registered Establishments with MER ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to: 1)increase the number or investigational sites in the post-approval study of new patients (post-approval study#2) under the recurrent bulbar urethral strictures application, and 2) increase the patient enrollment limit to 132 (to include 57 original and 75 new patients) for the post-approval study of the bph application.