PMA P130022S006
- Device
- NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
- Applicant
- Nevro Corporation
- PMA number
- P130022
- Supplement
- S006
- Product code
- LGW
- Decision date
- 2016-04-15
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Process changes to the manufacture of the spinal cord stimulator system battery charger, including the addition of an adhesive to a component on the printed circuit board (PCB), minor alterations to the PCB layout to improve manufacturability, and the addition of torque wrenches to its manufacturing process.
Current openFDA PMA Record#
- Device
- NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
- Applicant
- Nevro Corporation
- PMA number
- P130022
- Supplement
- S006
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2016-04-15
- Decision code
- OK30
- Date received
- 2016-03-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Process changes to the manufacture of the spinal cord stimulator system battery charger, including the addition of an adhesive to a component on the printed circuit board (PCB), minor alterations to the PCB layout to improve manufacturability, and the addition of torque wrenches to its manufacturing process.