|
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 | S035 |
Date Received | 08/12/2020 |
Decision Date | 02/26/2021 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a new Nordson Medical’s manufacturing site of the Implantable Pulse Generators (IPGs) of the Senza neuromodulation system located at 105 E Tasman Dr. San Jose, CA, 95134. Pro-Tech will continue to perform final packaging and sterilization. |