Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Basic Information
- Device Name
- Stimulator, Electrical, Implanted, For Parkinsonian Tremor
- Trade Name
- Medtronic DBS Therapy for Epilepsy
- PMA Number
- P960009
- Supplement Number
- S318
- 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
- October 12, 2018
- Date Received
- May 24, 2018
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol
- Expedited Review
- N
Advisory Committee Statement
Approval for the Medtronic DBS Therapy for expanding the indications to include Epilepsy. Bilateral stimulation of the anterior nucleus of the thalamus (ANT) using the Medtronic DBS System for epilepsy is indicated as an adjunctive therapy for reducing the frequency of seizures in individuals 18 years of age or older diagnosed with epilepsy characterized by partial - onset seizures, with or without secondary generalization, that are refractory to three or more antiepileptic medications. The Medtronic DBS System for Epilepsy has demonstrated safety and effectiveness in patients who averaged six or more seizures per month over the three most recent months prior to implant of the DBS system (with no more than 30 days between seizures). The Medtronic DBS System for Epilepsy has not been evaluated in patients with less frequent seizures.
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 |