|
Trade Name | MEDTRONIC (ACTIVA)DEEP BRAIN STIMULATION FOR OCD THERAPY |
Classification Name | stimulator, brain, implanted, for behavior modification |
Generic Name | stimulator, brain, implanted, for behavior modification |
Applicant |
MEDTRONIC INC.,NEUROLOGICAL DIVISION |
7000 central avenue northeast |
minneapolis, MN 55432 |
|
HDE Number | H050003 |
Supplement Number | S001 |
Date Received | 06/30/2009 |
Decision Date | 09/16/2009 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | normal 75 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for labeling changes with regard to use of magnetic resonant imaging (mri) and implanting instructions for the lead cap. |