Activa Deep Brain Stimulation Therapy System
FDA premarket approval P960009/S307 · decided 2018-01-09
Approval details
- PMA number
- P960009
- Supplement
- S307
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Activa Deep Brain Stimulation Therapy System
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2017-12-15
- Decision date
- 2018-01-09
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Qualification of plasma treatment of Neuro molded components on additional plasma reactor at Medtronic Energy and Component Center (MECC), internal supplier of plasma treated polysulfone components for Medtronic Neuromodulation.
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