|
Device | ACTIVA DEEP BRAIN STIMULATION (DBS) THERAPY |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S106 |
Date Received | 12/21/2010 |
Decision Date | 01/20/2011 |
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 TO ADD NEW PRECAUTIONS REQUIRED FOR COMPLIANCE WITH APPLICABLE PORTIONS OF THE ¿IEC 60601-1 STANDARD FOR MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE.¿ |