Algovita Spinal Cord Stimulation System
FDA premarket approval P130028/S015 · decided 2017-03-31
Approval details
- PMA number
- P130028
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Algovita Spinal Cord Stimulation System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nuvectra Corporation
- Date received
- 2017-02-28
- Decision date
- 2017-03-31
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Blaine, MN
- Statement
- Changes to the Implantable Pulse Generator printed circuit board (PCB) functional test system software in order to improve system reliability and to better conform to device performance specifications.
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