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 | Axium Neurostimulator System |
Generic Name | Dorsal root ganglion stimulator for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P150004 |
Supplement Number | S031 |
Date Received | 07/01/2019 |
Decision Date | 07/29/2019 |
Product Code |
PMP |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Move FMI manufacturing operations from its current site at Elk Grove Village, Illinois, USA to a facility in Lincolnshire, Illinois, USA. FMI is the currently approved supplier for molded silicone parts that go into the finished assembly and packaging of implantable pulse generators (IPGs), leads, lead extensions, lead adapters, and lead accessories. |
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