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 | Master Restore, Itrel®, Synergy®, Intellis™, Vanta™ Spinal Cord Stimulation Systems, Pisces™, Specify®, Vectris® Spinal |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | MEDTRONIC NEUROMODULATION 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432 |
PMA Number | P840001 |
Supplement Number | S525 |
Date Received | 08/05/2022 |
Decision Date | 11/02/2022 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an update to the Model A71200 Clinician Programming Application to correct two field performance issues and address several software anomalies that prevent the device from performing as intended. |
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