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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 NumberS017
Date Received08/01/2019
Decision Date08/29/2019
Product Code LNM 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
New vendor to supply the glucan powder for the subject device.
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