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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 NumberS021
Date Received01/23/2025
Decision Date03/13/2026
Product Code LNM 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
a change to the syringe cap of the 1 mL Durasphere device configuration
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