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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSt. Jude Medical Infinity DBS Implantable Pulse Generator
Generic Namestimulator, electrical, implanted, for parkinsonian tremor
Applicant
Abbott Medical
6901 prestion road
plano, TX 75024
PMA NumberP140009
Supplement NumberS039
Date Received07/11/2018
Decision Date01/02/2020
Product Codes NHL  PJS  MHY 
Docket Number 20M-0097
Notice Date 01/07/2020
Advisory Committee Neurology
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for expanding the indications to include bilateral stimulation of the internal globus pallidus (GPi) as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive Parkinsons disease that is not adequately controlled by medications.. This device is indicated for:1) Bilateral stimulation of the subthalamic nucleus (STN) or the internal GPi as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive Parkinsons disease that is not adequately controlled by medications; and2) Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of disabling upper extremity tremor in adult essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
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