Algovita Spinal Cord Stimulation System
FDA premarket approval P130028/S025 · decided 2019-12-31
Approval details
- PMA number
- P130028
- Supplement
- S025
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Algovita Spinal Cord Stimulation System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nuvectra Corporation
- Date received
- 2019-06-07
- Decision date
- 2019-12-31
- Days to decision
- 207 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Blaine, MN
- Statement
- Approval for whole-body MRI labeling indication for implanted components of the Algovita SCS System for use in closed bore, horizontal, static magnetic field strength of 1.5T MR environments.
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