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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 NumberS001
Date Received09/20/2007
Decision Date02/12/2008
Product Code NZC 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE STANDARD TETHER (ST) LENGTH MODIFICATION TO SIZE 7-9 SPANNER STENTS.
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