Algovita Spinal Cord Stimulation System
FDA premarket approval P130028/S027 · decided 2019-08-28
Approval details
- PMA number
- P130028
- Supplement
- S027
- Supplement type
- 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
- 2019-07-29
- Decision date
- 2019-08-28
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Blaine, MN
- Statement
- Implementation of an update to the injection molding process for the distal subassembly of the Algovita® 12-Electrode Percutaneous Leads, Trial Leads, and LeadExtensions.
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