Algovita Spinal Cord Stimulation System
FDA premarket approval P130028/S031 · decided 2020-05-05
Approval details
- PMA number
- P130028
- Supplement
- S031
- Supplement type
- Normal 180 Day Track
- 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
- 2019-11-05
- Decision date
- 2020-05-05
- Days to decision
- 182 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Blaine, MN
- Statement
- Approval use for the Algovita Clinician Programmer application and Nuvectra Bridge Communicator as per the letter dated May 5, 2020.
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