Algovita Spinal Cord Stimulation System (SCS), Trial Lead: 8/12 Electrode Percutaneous Lead Kit
FDA premarket approval P130028/S021 · decided 2018-06-28
Approval details
- PMA number
- P130028
- Supplement
- S021
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Algovita Spinal Cord Stimulation System (SCS), Trial Lead: 8/12 Electrode Percutaneous Lead Kit
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nuvectra Corporation
- Date received
- 2018-05-29
- Decision date
- 2018-06-28
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Blaine, MN
- Statement
- Changes to incorporate several process enhancements to the distal final bond and distal epoxy backfill manufacturing processes for the Percutaneous Leads and Trial Leads. The changes do not change the design of the Leads
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