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Trade Name | INSS FOR OBSESSIVE-COMPULSIVE DISORDER/LEAD KITS |
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 |
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HDE Number | H050003 |
Supplement Number | S026 |
Date Received | 07/29/2011 |
Decision Date | 08/26/2011 |
Product Code | |
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 labeling changes to the manual for the model 8840 n'vision clinician programmer. These changes include the addition of precautions related to modificationof the device, the effect of electromagnetic interference (emi) on telemetry communication, and the effects of battery corrosion. The changes also include updates to existing precautionary language to maintain consistency with other medtronic labeling for external programming devices. |