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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 NumberS005
Date Received04/21/2009
Decision Date05/19/2009
Product Code
NZC[ Registered Establishments with NZC ]
Advisory Committee Gastroenterology/Urology
Supplement Type Special Supplement
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of an in-process inflation test for the insertion tool.
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