PMA P190002S011

Device: Saluda Medical Evoke SCS System
Applicant: Saluda Medical Pty, Ltd.
PMA number: P190002
Supplement: S011
Product code: LGW
Decision date: 2022-08-09
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Approval for alternate Surface Pro tablet models, SP6 and SP7+, to be used for the Clinical Interface due to obsolescence of previous models.

Current openFDA PMA Record#

Device: Saluda Medical Evoke SCS System
Applicant: Saluda Medical Pty, Ltd.
PMA number: P190002
Supplement: S011
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2022-08-09
Decision code: APPR
Date received: 2022-05-11
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for alternate Surface Pro tablet models, SP6 and SP7+, to be used for the Clinical Interface due to obsolescence of previous models.