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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
ApplicantBoston Scientific Corporation
100 Boston Scientfic Way
Marlborough, MA 01752
PMA NumberP170023
Supplement NumberS024
Date Received06/02/2026
Decision Date07/01/2026
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  
Manufacturing the Bulkamid Hydrogel in new cleanrooms at the existing manufacturing site.
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