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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 NumberS007
Date Received11/24/2020
Decision Date12/17/2020
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
Approval Order Statement  
a change in the sterilization site of the Bulkamid Needle, a component of the Bulkamid Urethral Bulking System
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