|
Device | MEDTRONIC ACTIVA DEEP BRAIN STIMULATION (DBS) SYSTEM |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S037 |
Date Received | 02/06/2006 |
Decision Date | 03/01/2006 |
Product Code |
MHY |
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 MINOR MODIFICATIONS TO THE LABELING WITH RESPECT TO THE MRI (MAGNETIC RESONANCE IMAGING) INSTRUCTIONS; AND FOR REMOVING THE ?MRI AND ACTIVA THERAPY? APPENDIX FROM THE LABELING AND REPLACING IT WITH A STAND-ALONE MRI GUIDELINES DOCUMENT. |