Master Intellis Spinal Cord Stimulation Systems
FDA premarket approval P840001/S529 · decided 2023-08-08
Approval details
- PMA number
- P840001
- Supplement
- S529
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Master Intellis Spinal Cord Stimulation Systems
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Medtronic Neuromodulation
- Date received
- 2022-09-09
- Decision date
- 2023-08-08
- Days to decision
- 333 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for a manufacturing site located at Medline Industries/Centurion Medical Products Corporation (FEI: 3005846326) Tri-State de Mexico, S. de R.L. de C.V. Calzada Presidente Venustiano Carranza, No. 301 Desarrollo Industrial Colorado Mexicali, Baja California, 21397, MEXICO as an alternate facility for kitting and final packaging of the Medtronic Model 97725 Wireless External Neurostimulator (ENS). Addition of Medline Industries, LP. (FEI: 3015173212) Mexicali Directo Al Cliente S. De R.L.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |