HFX App
FDA premarket approval P130022/S049 · decided 2023-08-01
Approval details
- PMA number
- P130022
- Supplement
- S049
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HFX App
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nevro Corporation
- Date received
- 2023-04-28
- Decision date
- 2023-08-01
- Days to decision
- 95 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval for the Patient Therapy Application, HFX, to be used on Android devices.
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