|
Device | 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 | S010 |
Date Received | 10/20/2016 |
Decision Date | 12/28/2016 |
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 manufacturing site located at Pro-Tech, 4041 Express Street, Arlington, Texas for kitting of components in cleanrooms, final packaging including labeling and visual inspection of the final product prior to shipment for sterilization. |