Premarket Approval (PMA)

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.

• Device: St. Jude Medical Infinity DBS Implantable Pulse Generator
• Generic Name: Stimulator, electrical, implanted, for parkinsonian tremor
• Applicant: Abbott Medical; 6901 Prestion Road; Plano, TX 75024
• PMA Number: P140009
• Supplement Number: S039
• Date Received: 07/11/2018
• Decision Date: 01/02/2020
• Product Codes: MHY NHL PJS
• Docket Number: 20M-0097
• Notice Date: 01/07/2020
• Advisory Committee: Neurology
• Supplement Type: Panel 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