MEDTRONIC DBS THERAPY FOR EPILEPSY
FDA premarket approval P960009/S219 · decided 2018-04-27
Approval details
- PMA number
- P960009
- Supplement
- S219
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDTRONIC DBS THERAPY FOR EPILEPSY
- Generic name
- Stimulator, thalamic, epilepsy, implanted
- Applicant
- Medtronic, Inc.
- Date received
- 2015-02-24
- Decision date
- 2018-04-27
- Days to decision
- 1158 days
- Decision code
- APPR
- Product code
- MBX
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- 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 DB
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