PMA P130022S015
- Device
- Senza Spinal Cord Stimulation (SCS) System
- Applicant
- Nevro Corporation
- PMA number
- P130022
- Supplement
- S015
- Product code
- LGW
- Decision date
- 2017-08-09
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Second contract manufacturer (Sparton) conduct manufacturing activities for one of Senzas system components (called Trial Stimulator).
Current openFDA PMA Record#
- Device
- Senza Spinal Cord Stimulation (SCS) System
- Applicant
- Nevro Corporation
- PMA number
- P130022
- Supplement
- S015
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2017-08-09
- Decision code
- OK30
- Date received
- 2017-07-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Second contract manufacturer (Sparton) conduct manufacturing activities for one of Senzas system components (called Trial Stimulator).