PMA P130022S007

Device: SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
Applicant: Nevro Corporation
PMA number: P130022
Supplement: S007
Product code: LGW
Decision date: 2016-11-18
Classification: Stimulator, Spinal-cord, Totally Implanted For Pain Relief
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Approval to use a larger volume of sterilization load (from 4 pallets to 10 pallets) for the ethylene oxide (EO) sterilization of Senza SCS System products.

Current openFDA PMA Record#

Device: SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
Applicant: Nevro Corporation
PMA number: P130022
Supplement: S007
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2016-11-18
Decision code: APPR
Date received: 2016-04-11
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval to use a larger volume of sterilization load (from 4 pallets to 10 pallets) for the ethylene oxide (EO) sterilization of Senza SCS System products.