PMA P960009S219
- Device
- MEDTRONIC DBS THERAPY FOR EPILEPSY
- Applicant
- Medtronic, Inc.
- PMA number
- P960009
- Supplement
- S219
- Product code
- MBX
- Decision date
- 2018-04-27
- Generic name
- Stimulator, thalamic, epilepsy, implanted
- Approval order 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.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P960009S219B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- MEDTRONIC DBS THERAPY FOR EPILEPSY
- Applicant
- Medtronic, Inc.
- PMA number
- P960009
- Supplement
- S219
- Product code
- MBX
- Generic name
- Stimulator, thalamic, epilepsy, implanted
- Decision date
- 2018-04-27
- Decision code
- APPR
- Date received
- 2015-02-24
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order 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.