Algovita Spinal Cord Stimulation System
FDA premarket approval P130028/S018 · decided 2018-11-28
Approval details
- PMA number
- P130028
- Supplement
- S018
- 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
- 2017-06-12
- Decision date
- 2018-11-28
- Days to decision
- 534 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Blaine, MN
- Statement
- approval for new MR Conditional labeling limited to transmit/receive head coils and head scans only for the implanted components of the Algovita SCS System.
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