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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.
 
DeviceAxonics Sacral Neuromodulation System
Generic NameImplanted electrical device intended for treatment of fecal incontinence
Regulation Number876.5270
ApplicantBoston Scientific Corporation
100 Boston Scientfic Way
Marlborough, MA 01752
PMA NumberP190006
Supplement NumberS017
Date Received06/12/2020
Decision Date07/10/2020
Product Code QON 
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  
Axonics Charging Device uses a printed circuit board assembly (PCBA) that is currently tested manually using test procedure, 120-0113 (VOL# 27, file #009 of original submission). To support an increase in production, Axonics developed a test fixture (# 200-0198-001, built with software 150-0113-001) that automates the tests that are in the original manual test procedure. A complete traceability of test steps in the original manual test procedure to the proposed automated test fixture requirements is provided.
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