Algovita Spinal Cord Stimulation System
FDA premarket approval P130028/S022 · decided 2018-09-20
Approval details
- PMA number
- P130028
- Supplement
- S022
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Algovita Spinal Cord Stimulation System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nuvectra Corporation
- Date received
- 2018-06-22
- Decision date
- 2018-09-20
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Blaine, MN
- Statement
- Approval for modifying the design of the Algovita Model 4200 Programmer Charger cable, and the Model 4230 Charging Paddle cable to improve the mechanical reliability (flex reliability) of the cables.
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