|
Device | MEDTRONIC SPINAL CORD STIMULATION SYSTEMS |
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 | S261 |
Date Received | 02/11/2014 |
Decision Date | 03/13/2014 |
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 CHANGES BEING EFFECTED TO THE LABELING OF MEDTRONIC SPINAL CORD STIMULATION SYSTEMS. SPECIFICALLY, A POSSIBLE ADVERSE EVENT DELAYED SPINAL CORD COMPRESSION DUE TO EPIDURAL MASS FORMATION IS BEING ADDED TO THE LABELING |