PMA P130028S021
- Device
- Algovita Spinal Cord Stimulation System (SCS), Trial Lead: 8/12 Electrode Percutaneous Lead Kit
- Applicant
- Nuvectra Corporation
- PMA number
- P130028
- Supplement
- S021
- Product code
- LGW
- Decision date
- 2018-06-28
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Changes to incorporate several process enhancements to the distal final bond and distal epoxy backfill manufacturing processes for the Percutaneous Leads and Trial Leads. The changes do not change the design of the Leads
Current openFDA PMA Record#
- Device
- Algovita Spinal Cord Stimulation System (SCS), Trial Lead: 8/12 Electrode Percutaneous Lead Kit
- Applicant
- Nuvectra Corporation
- PMA number
- P130028
- Supplement
- S021
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2018-06-28
- Decision code
- OK30
- Date received
- 2018-05-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to incorporate several process enhancements to the distal final bond and distal epoxy backfill manufacturing processes for the Percutaneous Leads and Trial Leads. The changes do not change the design of the Leads