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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
Classification Namestent, urethral, prostatic, semi-permanent
Generic Namestent, urethral, prostatic, semi-permanent
Applicant
SRS MEDICAL
76 treble cove road, #3
north billerica, MA 01862
PMA NumberP060010
Supplement NumberS011
Date Received04/24/2013
Decision Date08/28/2013
Product Code
NZC[ Registered Establishments with NZC ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A MANUFACTURING SITE LOCATED AT PROMED PHARMA LLC, IN MINNEAPOLIS, MINNESOTA.
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