PMA P130022S019
- Device
- Senza Spinal Cord Stimulation (SCS) System
- Applicant
- Nevro Corporation
- PMA number
- P130022
- Supplement
- S019
- Product code
- LGW
- Decision date
- 2019-02-08
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Approval for conditional Magnetic Resonance labeling for the Senza Implantable Pulse Generator (IPG) model IPG2000.
Current openFDA PMA Record#
- Device
- Senza Spinal Cord Stimulation (SCS) System
- Applicant
- Nevro Corporation
- PMA number
- P130022
- Supplement
- S019
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2019-02-08
- Decision code
- APPR
- Date received
- 2018-08-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for conditional Magnetic Resonance labeling for the Senza Implantable Pulse Generator (IPG) model IPG2000.