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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
ApplicantSRS MEDICAL
PMA NumberP060010
Supplement NumberS010
Date Received05/20/2011
Decision Date07/28/2011
Product Code
NZC[ Registered Establishments with NZC ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a design change to add an access tether, called the shore line to the device.
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