Algovita Spinal Cord Stimulation System
FDA premarket approval P130028/S014 · decided 2017-05-12
Approval details
- PMA number
- P130028
- Supplement
- S014
- 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
- 2017-02-17
- Decision date
- 2017-05-12
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Blaine, MN
- Statement
- Approval for the removal of sleep mode functionality and the modification of the boot logo branding for the device.
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