PMA P960009S357

Device: Deep Brain Stimulation Therapy System for Parkinson's Disease
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S357
Product code: MHY
Decision date: 2019-09-04
Classification: Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement: Approval of the Changes Being Effected (CBE) for the Deep Brain Stimulation Therapy System for Parkinson's Disease. The changes being effected include changes to Medtronic DBS Therapy physician and patient labeling, to enhance and harmonize the information regarding the risks of depression, suicide ideation, and suicide across the device type.

Current openFDA PMA Record#

Device: Deep Brain Stimulation Therapy System for Parkinson's Disease
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S357
Product code: MHY
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Decision date: 2019-09-04
Decision code: APPR
Date received: 2019-08-05
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval of the Changes Being Effected (CBE) for the Deep Brain Stimulation Therapy System for Parkinson's Disease. The changes being effected include changes to Medtronic DBS Therapy physician and patient labeling, to enhance and harmonize the information regarding the risks of depression, suicide ideation, and suicide across the device type.