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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 Rd., #3
North Billerica, MA 01862
PMA NumberP060010
Supplement NumberS005
Date Received04/21/2009
Decision Date05/19/2009
Product Code NZC 
Advisory Committee Gastroenterology/Urology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF AN IN-PROCESS INFLATION TEST FOR THE INSERTION TOOL.
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