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 | Restore, Itrel, Synergy, and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimu |
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 | S450 |
Date Received | 12/02/2019 |
Decision Date | 06/25/2020 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval for the new WR9200 Wireless Recharger Subsystem and associated labeling. The new WR9200 Wireless Recharger Subsystem is intended to recharge the Activa RC implantable neurostimulator (INS) for Deep Brain Stimulation Therapy and the following Restore INSs for Spinal Cord Stimulation Therapy: RestoreUltra; RestoreUltra SureScan MRI; RestoreSensor; and RestoreSensor SureScan MRI. |
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