Activa Deep Brain Stimulation Therapy System
FDA premarket approval P960009/S304 · decided 2018-05-26
Approval details
- PMA number
- P960009
- Supplement
- S304
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Activa Deep Brain Stimulation Therapy System
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2017-11-16
- Decision date
- 2018-05-26
- Days to decision
- 191 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for Medtronics new model A610 Activa Clinician Programmer application and Model 8880T2 Communicator intended for programming DBS systems and for a field-implementable update to the Model 37612 Activa RC implantable neurostimulator to extend the service life from 9 years to 15 years.
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