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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.
 
DeviceDurasphere Injectable Bulking Agent
Generic NameAGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
ApplicantCarbon Medical Technologies, Inc.
1290 Hammond Rd.
St. Paul, MN 55110
PMA NumberP980053
Supplement NumberS018
Date Received12/28/2020
Decision Date02/25/2021
Product Code LNM 
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 ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at Steris, 9303 West Broadway Ave., Brooklyn Park, MN 55445, a contract sterilizer.
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