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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 NumberS005
Date Received09/04/2020
Decision Date12/02/2020
Product Code LNM 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for minor changes to the Bulkamid Needle, including a change in the manufacturer for the Bulkamid Needle, which includes minor changes to the needle hubs outershape, the raw materials used for the needle hub and sterile barrier system (pouch), and the dimensions of the needle pouch.
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