Algovita Spinal Cord Stimulation System
FDA premarket approval P130028/S028 · decided 2020-02-12
Approval details
- PMA number
- P130028
- Supplement
- S028
- Supplement type
- 135 Review Track For 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
- 2019-08-12
- Decision date
- 2020-02-12
- Days to decision
- 184 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Blaine, MN
- Statement
- Approval for implementation of a modified reflow process to bond the polyurethane tip plug to the molded component of the distal end of the Algovita leads.
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