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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 NameTHE SPANNER TEMPORARY PROSTATIC STENT
Classification Namestent, urethral, prostatic, semi-permanent
ApplicantABBEYMOOR MEDICAL INC.
PMA NumberP060010
Supplement NumberS004
Date Received03/16/2009
Decision Date04/14/2009
Product Code
NZC[ Registered Establishments with NZC ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in silicone lubrication and the addition of a coating to a spanner component.
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