|
Trade Name | RECLAIM DEEP BRAIN STIMULATION FOR OBSESSIVE COMPULSIVE DISORDER (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 | S056 |
Date Received | 02/07/2013 |
Decision Date | 06/19/2013 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for firmware changes intended to correct device behaviors that result in temporary loss of stimulation (exception bit) and can affect programmed stimulation parameters (over-discharge). |