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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 | S315 |
Date Received | 01/29/2024 |
Decision Date | 04/09/2024 |
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 a minor design change to a radio frequency (rf) pin diode of the telemetry-m (tel-m) communication circuit and consequent minor change to the printed circuit board (pcb) used on the intellis 8880t2 (clinician telemetry module, ctm2), 97745 / 97745fa (programmer patient therapy manager, ptm3), and 97745nt (programmer patient therapy manager, ptm3 no bluetooth). |