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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 NumberS013
Date Received06/22/2020
Decision Date10/07/2022
Product Code NZC 
Docket Number 22M-2543
Notice Date 10/17/2022
Advisory Committee Gastroenterology/Urology
Clinical TrialsNCT02643849
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Spanner Prostatic Stent. The device is intended for temporary use (up to 30 days) to maintain urine flow and allow voluntary urination for patients who are not candidates for pharmacologic, minimally invasive or surgical treatment of the prostate.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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