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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.
 
DeviceSPANNER TEMPORARY PROSTATIC STENT WITH DISTAL CURVE DESIGN CHANGE
Generic NameStent, urethral, prostatic, semi-permanent
ApplicantSRS MEDICAL
76 TREBLE COVE ROAD, #3
NORTH BILLERICA, MA 01862
PMA NumberP060010
Supplement NumberS003
Date Received01/12/2009
Decision Date03/10/2009
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 TO ADD 45 DEGREE CURVE IN THE DISTAL PORTION OF THE STENT.
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