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Trade Name | Reclaim DDS 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 | S161 |
Date Received | 07/27/2017 |
Decision Date | 08/24/2017 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement A transfer of receiving and incoming inspection activities for device components (i. E. , screw-conn set, crimp block 7495, and block- connector, set screw) used in the manufacture of medtronic neuromodulation therapy delivery products, from the medtronic rice creek facility to the medtronic puerto rico operations company (mproc)-villalba, mproc-juncos, and the fedex/3pl (third party logistics) facility in guaynabo, puerto rico. |