|
Device | WaveWriter Alpha™ Spinal Cord Stimulator (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 | S365 |
Date Received | 08/08/2023 |
Decision Date | 11/06/2023 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of a minor labelling update to allow MR Conditionality for the Precision SCS S8 and M8 Adapters. |