PMA P130022S034

Device: Senza Spinal Cord Stimulation (SCS) System
Applicant: Nevro Corporation
Product code: LGW
Decision date: 2021-05-21
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Approval for the addition of an alternative site, Cirtec Medical Corporation Free Zone Coyol, Building 11 Costa Rica CR 20101, as a back up to the primary site Cirtec Medical, formerly known as Stellar, Brooklyn Park, MN for the manufacturing of the percutaneous lead components to accommodate higher volume manufacturing.

Current openFDA PMA Record#

Device: Senza Spinal Cord Stimulation (SCS) System
Applicant: Nevro Corporation
PMA number: P130022
Supplement: S034
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2021-05-21
Decision code: APPR
Date received: 2020-05-18
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the addition of an alternative site, Cirtec Medical Corporation Free Zone Coyol, Building 11 Costa Rica CR 20101, as a back up to the primary site Cirtec Medical, formerly known as Stellar, Brooklyn Park, MN for the manufacturing of the percutaneous lead components to accommodate higher volume manufacturing.