Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: Medtronic DBS Therapy for Epilepsy
• Generic Name: Stimulator, electrical, implanted, for parkinsonian tremor
• Applicant: MEDTRONIC Inc.; 7000 CENTRAL AVENUE NE; MINNEAPOLIS, MN 55432-3576
• PMA Number: P960009
• Supplement Number: S318
• Date Received: 05/24/2018
• Decision Date: 10/12/2018
• Product Code: MHY
• Advisory Committee: Neurology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: No

Approval Order 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.