Senza HFX iQ System (model IPG3000)
FDA premarket approval P130022/S048 · decided 2023-05-12
Approval details
- PMA number
- P130022
- Supplement
- S048
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Senza HFX iQ System (model IPG3000)
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nevro Corporation
- Date received
- 2023-02-13
- Decision date
- 2023-05-12
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval for use of an alternate battery component, the Contego 440, for the IPG3000 device model of the Senza HFX iQ System.
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