Stimulator, Thalamic, Epilepsy, Implanted
Basic Information
- Device Name
- Stimulator, Thalamic, Epilepsy, Implanted
- Trade Name
- MEDTRONIC DBS THERAPY FOR EPILEPSY
- PMA Number
- P960009
- Supplement Number
- S219
- Device Class
- FDA Class 3
- Product Code
- MBX
- Generic Name
- Stimulator, thalamic, epilepsy, implanted
- Medical Specialty
- Unknown
- Advisory Committee
- Neurology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- April 27, 2018
- Date Received
- February 24, 2015
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
- Docket Number
- 18M-1727
Advisory Committee Statement
Approval to expand the indications for the Medtronic DBS system 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 for patients who average 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 |
|---|---|---|---|
| MBX | Stimulator, Thalamic, Epilepsy, Implanted | FDA class 3 | Unknown |