Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Basic Information
- Device Name
- Stimulator, Electrical, Implanted, For Parkinsonian Tremor
- Trade Name
- St. Jude Medical Infinity DBS Implantable Pulse Generator
- PMA Number
- P140009
- Supplement Number
- S039
- Device Class
- FDA Class 3
- Product Code
- MHY
- Generic Name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Medical Specialty
- Unknown
- Advisory Committee
- Neurology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- January 2, 2020
- Date Received
- July 11, 2018
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
- Docket Number
- 20M-0097
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MHY | Stimulator, Electrical, Implanted, For Parkinsonian Tremor | FDA class 3 | Unknown |