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Device | Algovita Spinal Cord Stimulation (SCS): 12-Electrode Percutaneous Leads, and Trial Leads |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Nuvectra Corporation 10675 NAPLES STREET NE BLAINE, MN 55449 |
PMA Number | P130028 |
Supplement Number | S023 |
Date Received | 05/02/2019 |
Decision Date | 05/31/2019 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Implementation of an update to the injection molding process for the distal subassembly of the Algovita Spinal Cord Stimulation (SCS) Leads. |