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Trade Name | Reclaim DBS Therapy for Obsessive Compulsive Disorder (OCD) System |
Classification Name | deep brain stimulator for obsessive compulsive disorder (ocd) |
Generic Name | deep brain stimulator for obsessive compulsive disorder (ocd) |
Applicant |
MEDTRONIC INC.,NEUROLOGICAL DIVISION |
7000 central avenue northeast |
minneapolis, MN 55432 |
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HDE Number | H050003 |
Supplement Number | S206 |
Date Received | 02/14/2019 |
Decision Date | 04/26/2019 |
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 Correct the value for the electrode surface area used in the charge density calculation from 0. 12 cm2 to 0. 06 cm2. The erroneous value of 0. 12 cm2 is currently used in the calculation to display the charge density warning notification when the activa cpa is used with an ens and twist lock cable. |