|
Device | MEDTRONIC ACTIVA DEEP BRAIN STIMULATION SYSTEMS |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S035 |
Date Received | 11/04/2005 |
Decision Date | 12/06/2005 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR RECOMMENDING MAXIMUM DISPLAYED HEAD SAR TO BE 0.1 W/KG WITH RESPECT TO THE MRI (MAGNETIC RESONANCE IMAGING) INSTRUCTIONS. |
Post-Approval Study | Show Report Schedule and Study Progress |