PMA P960009S514

Device: Activa™ Deep Brain Stimulation Therapy System
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S514
Product code: MHY
Decision date: 2025-12-17
Classification: Neurology
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement: approval for using real-world evidence (RWE) from the Medtronic Registry for Epilepsy (MORE registry) as an alternative approach for the Epilepsy Post- Approval Study (EPAS study, P960009/S433) to meet the conditions of approval outlined in the FDA approval order for P960009/S219

Current openFDA PMA Record#

Device: Activa™ Deep Brain Stimulation Therapy System
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S514
Product code: MHY
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Decision date: 2025-12-17
Decision code: APPR
Date received: 2025-07-21
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval for using real-world evidence (RWE) from the Medtronic Registry for Epilepsy (MORE registry) as an alternative approach for the Epilepsy Post- Approval Study (EPAS study, P960009/S433) to meet the conditions of approval outlined in the FDA approval order for P960009/S219