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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTHE SPANNER TEMPORARY PROSTATIC STENT
Generic NameStent, urethral, prostatic, semi-permanent
ApplicantSRS MEDICAL
76 TREBLE COVE ROAD, #3
NORTH BILLERICA, MA 01862
PMA NumberP060010
Supplement NumberS007
Date Received04/28/2009
Decision Date06/26/2009
Product Code NZC 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATION OF THE SPANNER PROXIMAL TUBE ASSEMBLY TO REPLACE THE STAINLESS STEEL COIL WITH A HIGH DUROMETER SILICONE SLEEVE.
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