PMA P190002S001

Device: Saluda Medical Evoke® SCS System
Applicant: Saluda Medical Pty, Ltd.
Product code: LGW
Decision date: 2022-10-26
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Approval to move the current cleanroom facilities located at 14 Mars Rd, Lane Cove, NSW, Australia (Lane Cove) to 5 Eden Park Drive, Macquarie Park, NSW, Australia (Macquarie Park) and approval to duplicate external device production from the current Artarmon facility (407 Pacific Highway, Artarmon, NSW, Australia) to the Macquarie Park facility.

Current openFDA PMA Record#

Device: Saluda Medical Evoke® SCS System
Applicant: Saluda Medical Pty, Ltd.
PMA number: P190002
Supplement: S001
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2022-10-26
Decision code: APPR
Date received: 2022-03-03
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval to move the current cleanroom facilities located at 14 Mars Rd, Lane Cove, NSW, Australia (Lane Cove) to 5 Eden Park Drive, Macquarie Park, NSW, Australia (Macquarie Park) and approval to duplicate external device production from the current Artarmon facility (407 Pacific Highway, Artarmon, NSW, Australia) to the Macquarie Park facility.