PMA P130028S018
- Device
- Algovita Spinal Cord Stimulation System
- Applicant
- Nuvectra Corporation
- PMA number
- P130028
- Supplement
- S018
- Product code
- LGW
- Decision date
- 2018-11-28
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- approval for new MR Conditional labeling limited to transmit/receive head coils and head scans only for the implanted components of the Algovita SCS System.
Current openFDA PMA Record#
- Device
- Algovita Spinal Cord Stimulation System
- Applicant
- Nuvectra Corporation
- PMA number
- P130028
- Supplement
- S018
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2018-11-28
- Decision code
- APPR
- Date received
- 2017-06-12
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for new MR Conditional labeling limited to transmit/receive head coils and head scans only for the implanted components of the Algovita SCS System.