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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.
 
DeviceHFX Dynamis System
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantNevro Corporation
1800 Bridge Pkwy.
Redwood City, CA 94065
PMA NumberP130022
Supplement NumberS069
Date Received04/18/2025
Decision Date08/18/2026
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  
This supplement (S069) requested approval for the next generation implantable pulse generator system referred to as the HFX Dynamis System. The HFX Dynamis System is designed to deliver a new stimulation therapy, Bolus 10kHz, and support expanded MRI access to allow for scanning with one broken conductor per percutaneous lead. The key changes approved in this supplement include: a new Implantable Pulse Generator model (IPG3500), an updated Patient Application (PTA10043, v3.0.0), and updated Clinician Programmer Software (v4.0). The device, as modified, will be marketed under the trade name HFX Dynamis System and is indicated as follows:The HFX Dynamis System, HFX iQ System and HFX Trial System are indicated as aids in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain, and leg pain. The HFX Dynamis System, HFX iQ System and HFX Trial System, when programmed to include a frequency of 10 kHz, are indicated as aids in the management of chronic intractable pain of the lower limbs, including unilateral or bilateral pain, associated with diabetic neuropathy. The HFX Dynamis System, HFX iQ System and HFX Trial System, when programmed to include a frequency of 10 kHz, are indicated as aids in the management of non-surgical refractory back pain (intractable back pain without prior surgery and not a candidate for back surgery). FDA's review of this PMA supplement also included the review and approval of a PCCP: Juno Predetermined Change Control Plan, Rev A., which includes two future firmware modifications: 1. Disabling the 1 MHz ASIC clock while in MRI Mode for the IPG3000 and IPG3500, to reduce RF artifacts in MRI images; and 2. Optimizing power consumption for bolus therapy programs by disabling the ASIC during the bolus Macro Off Time, applicable to the IPG3500 only.
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