Senza Spinal Cord Stimulation (SCS) System and HFX iQ System
FDA premarket approval P130022/S058 · decided 2024-09-24
Approval details
- PMA number
- P130022
- Supplement
- S058
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Senza Spinal Cord Stimulation (SCS) System and HFX iQ System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nevro Corporation
- Date received
- 2024-03-28
- Decision date
- 2024-09-24
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval for an update to the Clinical Summary manual to add 24-month results from their Senza-PDN study to demonstrate long-term safety and effectiveness of 10 kHz SCS therapy in treating painful diabetic neuropathy (PDN) patients.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.