Infinity Neurostimulation System
FDA premarket approval P140009/S023 · decided 2017-05-01
Approval details
- PMA number
- P140009
- Supplement
- S023
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Infinity Neurostimulation System
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- ABBOTT MEDICAL
- Date received
- 2017-02-14
- Decision date
- 2017-05-01
- Days to decision
- 76 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Approval for updated Firmware version 1.2.
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