Intellis Spinal Cord Stimulation System (SCS Systems)
FDA premarket approval P840001/S510 · decided 2022-02-17
Approval details
- PMA number
- P840001
- Supplement
- S510
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Intellis Spinal Cord Stimulation System (SCS Systems)
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2022-01-18
- Decision date
- 2022-02-17
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Update to the visual inspection requirements of the Intellis flex circuit laser solder joint print specification and process qualification in order to align with the sponsors current Neurostimulator designs including the elimination of the solder joint visual inspection requirements for the Component Side of the flex.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |