|
Device | Spectra WaveWriter Spinal Cord Stimulator System |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Boston Scientific Corp. 25155 Rye Canyon Loop Valencia, CA 91355 |
PMA Number | P030017 |
Supplement Number | S302 |
Date Received | 09/25/2017 |
Decision Date | 12/22/2017 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for minor updates to firmware/software and microcontroller on the Printed Circuit Board Assembly (PCBA) of Boston Scientific's Freelink Remote Control (RC) associated with their Spectra WaveWriter SCS system, and updates to support the addition of two new features as well as enhancement to existing features in their Clinician Programming software. |