PMA P130022S011
- Device
- NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
- Applicant
- Nevro Corporation
- PMA number
- P130022
- Supplement
- S011
- Product code
- LGW
- Decision date
- 2017-01-17
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Packaging configuration change (i.e., pre-loaded percutaneous lead with the 0.014” curved stylet) to the Senza SCS System.
Current openFDA PMA Record#
- Device
- NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
- Applicant
- Nevro Corporation
- PMA number
- P130022
- Supplement
- S011
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2017-01-17
- Decision code
- OK30
- Date received
- 2016-12-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Packaging configuration change (i.e., pre-loaded percutaneous lead with the 0.014” curved stylet) to the Senza SCS System.