| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | Master Intellis Spinal Cord Stimulation Systems |
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| Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
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| Applicant | Medtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432 |
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| PMA Number | P840001 |
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| Supplement Number | S529 |
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| Date Received | 09/09/2022 |
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| Decision Date | 08/08/2023 |
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| Product Code |
LGW |
| Advisory Committee |
Neurology |
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| Supplement Type | Normal 180 Day Track No User Fee |
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| Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order 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. De C.V. Circuito Del Desierto #71-A Parque Industrial del Desierto Mexicali Baja California 21395 Mexico as an alternate facility for sterilization of the Medtronic Model 97725 Wireless External Neurostimulator (ENS). The Model 97725 ENS shall be sterile packaged in an ISO certified controlled environment area (CEA) - ISO 14644-1 [class 8] or better. |
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