|
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 | S015 |
Date Received | 07/14/2017 |
Decision Date | 08/09/2017 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Second contract manufacturer (Sparton) conduct manufacturing activities for one of Senzas system components (called Trial Stimulator). |