Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™

FDA premarket approval P960009/S422 · decided 2022-03-25

Approval details

PMA number

P960009

Supplement

S422

Supplement type

Normal 180 Day Track No User Fee

Supplement reason

Postapproval Study Protocol

Trade name

Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™

Generic name

Stimulator, electrical, implanted, for parkinsonian tremor

Applicant

Medtronic, Inc.

Date received

2022-02-24

Decision date

2022-03-25

Days to decision

29 days

Decision code

APPR

Product code

MHY

Advisory committee

Neurology

Expedited review

No

Location

Minneapolis, MN

Statement

Approval of the following revisions to the protocol for the post-approval study (PAS), DBS for Epilepsy New Enrollment PAS: a) evaluate seizure worsening and changes in seizure frequency over time without formal hypothesis testing for safety; b) change the sample size for the primary effectiveness objective to approximately 72 evaluable subjects at 3 years (140 enrolled subjects to have 90 implanted subjects) from 112 evaluable subjects at 3 years (216 enrolled subjects to have 140 implanted sub

510(k) clearances by this applicant