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Device | Deep Brain Stimulation Therapy System for Parkinson's Disease |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S357 |
Date Received | 08/05/2019 |
Decision Date | 09/04/2019 |
Product Code |
MHY |
Advisory Committee |
Neurology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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. |