|
Device | Restore, Itrel, and Synergy Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimulation Leads |
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 | S416 |
Date Received | 11/19/2018 |
Decision Date | 12/19/2018 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for labeling changes to Medtronic Spinal Cord Stimulation (SCS) labeling. |