Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Basic Information
- Device Name
- Stimulator, Electrical, Implanted, For Parkinsonian Tremor
- Trade Name
- ACTIVA PC IMPLANTABLE NEUROSTIMULATION SYSTEM
- PMA Number
- P960009
- Supplement Number
- S052
- 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
- April 7, 2009
- Date Received
- June 6, 2008
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR NEW ACTIVA PC IMPLANTABLE NEUROSTIMULATION SYSTEM (INS), INTENDED FOR DEEP BRAIN STIMULATION (DBS). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THETRADE NAME ACTIVA PC AND IS INDICATED FOR THE FOLLOWING:PARKINSON'S CONTROL THERAPYBILATERAL STIMULATION OF THE INTERNAL GLOBUS PALLIDUS (GPI) OR THE SUBTHALAMIC NUCLEUS (STN)USING MEDTRONIC ACTIVA PARKINSON'S CONTROL THERAPY IS INDICATED FOR ADJUNCTIVE THERAPY IN REDUCING SOME OF THE SYMPTOMS OF ADVANCED, LEVODOPARESPONSIVE PARKINSON'S DISEASE THAT ARE NOT ADEQUATELY CONTROLLED WITH MEDICATION.TREMOR CONTROL THERAPYUNILATERAL THALAMIC STIMULATION BY THE MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM IS INDICATED FOR THE SUPPRESSION OF TREMOR IN THE UPPER EXTREMITY. THE SYSTEM IS INTENDED FOR USE INPATIENTS WHO ARE DIAGNOSED WITH ESSENTIAL TREMOR OR PARKINSONIAN TREMOR NOT ADEQUATELYCONTROLLED BY MEDICATIONS AND WHERE THE TREMOR CONSTITUTES A SIGNIFICANT FUNCTIONAL DISABILITY.
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 |