|
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 | S001 |
Date Received | 09/02/2015 |
Decision Date | 10/02/2015 |
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 MODIFICATION IN THE MANUFACTURING PROCESS OF THE CONNECTOR STACK SUB-ASSEMBLY. |