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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.
 
DeviceNeuspera Sacral Neuromodulation (SNM) System
Generic NameStimulator, electrical, implantable, for incontinence
Regulation Number876.5270
ApplicantNeuspera Medical, Inc.
51 Daggett Dr.
San Jose, CA 95134
PMA NumberP240031
Supplement NumberS005
Date Received06/01/2026
Decision Date08/21/2026
Product Code EZW 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for extension of the shelf life for the Trial System Kit, Trial Lead Kit, and External Procedural Kit of the Neuspera Trial System
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