|
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 | S030 |
Date Received | 05/02/2019 |
Decision Date | 07/31/2019 |
Product Code |
PMP |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for removal of the small curve delivery sheath from DRG SlimTip Trial Lead Kit (model MN10350-50A) and DRG SlimTip Implant Lead Kit (model MN10450-50A). |