PMA P130022S012
- Device
- NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
- Applicant
- Nevro Corporation
- PMA number
- P130022
- Supplement
- S012
- Product code
- LGW
- Decision date
- 2017-03-01
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Implement manufacturing process changes to allow for the use of virtual machine software (VMware) to provide an isolated and safe environment fromwhich to run the FDA approved PG2000 Clinician Programmer software v1.7.
Current openFDA PMA Record#
- Device
- NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
- Applicant
- Nevro Corporation
- PMA number
- P130022
- Supplement
- S012
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2017-03-01
- Decision code
- OK30
- Date received
- 2017-02-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement manufacturing process changes to allow for the use of virtual machine software (VMware) to provide an isolated and safe environment fromwhich to run the FDA approved PG2000 Clinician Programmer software v1.7.