Sequentia LT INS (Model 977005), Vanta INS with AdaptiveStim (Model 977006)
FDA premarket approval P840001/S535 · decided 2023-09-22
Approval details
- PMA number
- P840001
- Supplement
- S535
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Sequentia LT INS (Model 977005), Vanta INS with AdaptiveStim (Model 977006)
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2022-12-22
- Decision date
- 2023-09-22
- Days to decision
- 274 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for adding a new requirement and new behavior to the firmware and changing the `Stim off Charge Pump Amplitude' from the maximum value to the minimum value. When stimulation is off, the Charge Pump will be set to the minimum value. Adding a new risk control measure and new behavior to the firmware. Every 5 minutes the firmware will now reset the Tel-N Phase Lock Loop (PLL). The interface and requirement will also be changed, and new behavior will be added to the firmware. When the relev
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |