Medtronic DBS Therapy for Epilepsy

FDA premarket approval P960009/S318 · decided 2018-10-12

Approval details

PMA number

P960009

Supplement

S318

Supplement type

Normal 180 Day Track No User Fee

Supplement reason

Postapproval Study Protocol

Trade name

Medtronic DBS Therapy for Epilepsy

Generic name

Stimulator, electrical, implanted, for parkinsonian tremor

Applicant

Medtronic, Inc.

Date received

2018-05-24

Decision date

2018-10-12

Days to decision

141 days

Decision code

APPR

Product code

MHY

Advisory committee

Neurology

Expedited review

No

Location

Minneapolis, MN

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 Medt

510(k) clearances by this applicant