Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | Algovita Spinal Cord Stimulation System |
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 | S031 |
Date Received | 11/05/2019 |
Decision Date | 05/05/2020 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval use for the Algovita Clinician Programmer application and Nuvectra Bridge Communicator as per the letter dated May 5, 2020. |
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