Deep Brain Stimulation Therapy System for Parkinson's Disease
FDA premarket approval P960009/S357 · decided 2019-09-04
Approval details
- PMA number
- P960009
- Supplement
- S357
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Deep Brain Stimulation Therapy System for Parkinson's Disease
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2019-08-05
- Decision date
- 2019-09-04
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- 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.
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