|
Device | ITREL 3, SYNERGY AND SYNDERGY VERSITREL NEUROSTIMULATORS |
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 | S063 |
Date Received | 05/22/2002 |
Decision Date | 06/12/2002 |
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 UPDATING THE MAGNETIC RESONANCE IMAGING (MRI) TEXT IN THE SPINAL CORD STIMULATION PAIN THERAPY MANUALS. |