PMA P190002S006

Device: Saluda Medical Evoke SCS System
Applicant: Saluda Medical Pty, Ltd.
PMA number: P190002
Supplement: S006
Product code: LGW
Decision date: 2022-05-12
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Change in the sterilization process at Steris Applied Sterilization Technologies (Steris AST) by increased load density, reduction of injection pressure of EO gas (reduction in EO concentration), and updated chamber temperature specification and tolerances.

Current openFDA PMA Record#

Device: Saluda Medical Evoke SCS System
Applicant: Saluda Medical Pty, Ltd.
PMA number: P190002
Supplement: S006
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2022-05-12
Decision code: OK30
Date received: 2022-04-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change in the sterilization process at Steris Applied Sterilization Technologies (Steris AST) by increased load density, reduction of injection pressure of EO gas (reduction in EO concentration), and updated chamber temperature specification and tolerances.