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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceTHE SPANNER TEMPORARY PROSTATIC STENT
Generic NameStent, urethral, prostatic, semi-permanent
ApplicantSRS MEDICAL
76 TREBLE COVE ROAD, #3
NORTH BILLERICA, MA 01862
PMA NumberP060010
Date Received03/14/2006
Decision Date12/14/2006
Product Code NZC 
Docket Number 06M-0529
Notice Date 12/26/2006
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE SPANNER TEMPORARY PROSTATIC STENT. THE DEVICE IS INTENDED FOR TEMPORARY USE (UP TO 30 DAYS) TO MAINTAIN URINE FLOW AND ALLOW VOLUNTARY URINATION IN PATIENTS FOLLOWING MINIMALLY INVASIVE TREATMENT FOR BENIGN PROSTATIC HYPERPLASIA (BPH) AND AFTER INITIAL POST-TREATMENT CATHETERIZATION.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 
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