Intellis Spinal Cord Stimulation Systems
FDA premarket approval P840001/S465 · decided 2021-01-22
Approval details
- PMA number
- P840001
- Supplement
- S465
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Intellis Spinal Cord Stimulation Systems
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2020-07-20
- Decision date
- 2021-01-22
- Days to decision
- 186 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for an additional contract manufacturing site for kitting, sterilization, and final packaging of the Model 97725 Wireless External Neurostimulator (ENS) kit.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |