|
Device | Spectra WaveWriter SCS System, WaveWriter Alpha SCS System, WaveWriter Alpha Prime SCS 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 | S363 |
Date Received | 05/30/2023 |
Decision Date | 02/05/2024 |
Product Codes |
LGW QRB |
Docket Number | 24M-0603 |
Notice Date | 02/21/2024 |
Advisory Committee |
Neurology |
Clinical Trials | NCT04676022
|
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of the treatment of chronic intractable low back and leg pain without prior back surgery in the Indications for Use statement for the Spectra WaveWriter SCS System, WaveWriter Alpha SCS System, and WaveWriter Alpha Prime SCS System. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |