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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.
 
DeviceSenza® HFX iQ™ System
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantNevro Corporation
1800 Bridge Pkwy.
Redwood City, CA 94065
PMA NumberP130022
Supplement NumberS067
Date Received12/20/2024
Decision Date08/15/2025
Product Code LGW 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changes to the printed circuit board assembly (PCBA) board used in IPG3000, including replacing the microcontroller from rev 2 to rev 3, replacing the fuel gauge with a battery voltage measurement circuit, changing the material of the printed circuit board (PCB), moving the PCBA battery fuse from the negative terminal to the positive terminal, other minor modifications to PCB layout (reorganizing components and modification of solder pad size), as well as an alternate PCBA supplier for IPG3000.
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