|
Device | NEUROSTIMULATION SYSTEMS FOR SPINAL CORD STIMULATION (SCS) |
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 | S267 |
Date Received | 03/31/2014 |
Decision Date | 04/30/2014 |
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 TO PROVIDE CORRECTIONS TO THE LABELING RELATED TO THE CYCLING FEATURE (ALTERNATING BETWEEN THERAPY OFF AND ON) IN SOME NEUROSTIMULATION DEVICES USED FOR SPINAL CORD STIMULATION AND DEEP BRAIN STIMULATION. |