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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.
 
DeviceBulkamid Urethral Bulking System
Generic NameAGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
ApplicantAxonics Modulation Technologies, Inc.
26 Technology Drive
Irvine, CA 92618
PMA NumberP170023
Supplement NumberS015
Date Received04/17/2023
Decision Date07/12/2023
Product Code LNM 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for an additional Bulkamid Urethral Bulking System packaging configuration.
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