Restore, Itrel®, Synergy IntellisTM, VantaTM and InceptivTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and
FDA premarket approval P840001/S611 · decided 2025-10-16
Approval details
- PMA number
- P840001
- Supplement
- S611
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Restore, Itrel®, Synergy IntellisTM, VantaTM and InceptivTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2025-09-19
- Decision date
- 2025-10-16
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- for update to Energy and Components Center (MECC), specifically to update the Programmable Logic Controller (PLC) software to correct an AddUser function on the Medium Rate (MR) Cell Operating Fill Station (COS).
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 |