PMA P130028S004
- Device
- ALGOVITA SPINAL CORD STIMULATION SYSTEM
- Applicant
- Nuvectra Corporation
- PMA number
- P130028
- Supplement
- S004
- Product code
- LGW
- Decision date
- 2016-06-10
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Approval for the following changes to the 8- and 12-electrode lead extensions for your Algovita Spinal Cord Stimulation System:1) Decreasing your design specifications for the maximum insertion/withdrawal force from 2.0 lbf to 1.5 lbf;2) Revising your supplier shipping requirements for the spring system connector subassembly to have the subassembly shipped while threaded on a core pin; and 3) Elimination of the distal end strain relief.
Current openFDA PMA Record#
- Device
- ALGOVITA SPINAL CORD STIMULATION SYSTEM
- Applicant
- Nuvectra Corporation
- PMA number
- P130028
- Supplement
- S004
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2016-06-10
- Decision code
- APPR
- Date received
- 2016-03-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the following changes to the 8- and 12-electrode lead extensions for your Algovita Spinal Cord Stimulation System:1) Decreasing your design specifications for the maximum insertion/withdrawal force from 2.0 lbf to 1.5 lbf;2) Revising your supplier shipping requirements for the spring system connector subassembly to have the subassembly shipped while threaded on a core pin; and 3) Elimination of the distal end strain relief.