|
Device | Nevro Corp Senza Spinal Cord Stimulation (SCS) System |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Nevro Corporation 1800 Bridge Parkway Redwood City, CA 94065 |
PMA Number | P130022 |
Supplement Number | S029 |
Date Received | 10/15/2019 |
Decision Date | 06/09/2021 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for addition of an alternate supplier of the Hysol epoxy materials used to make the header component of the implantable pulse generator (IPG) of the Senza neuromodulation system |