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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceAxium Neurostimulator System
Generic NameDorsal root ganglion stimulator for pain relief
ApplicantABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024
PMA NumberP150004
Supplement NumberS069
Date Received02/22/2024
Decision Date10/08/2024
Product Code PMP 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of an alternate ethylene oxide (EO) sterilization site, Centerpiece Sterilization Corporation Cycle ABB-059-R, located in Tijuana, Mexico, for the following products:1) Abbott Medical Spinal Cord Stimulation (SCS) Systems: • Family of Proclaim, Proclaim XR & Proclaim Plus IPGs; Protégé MRI™ & Protégé IPGs; Prodigy MRI™ & Prodigy IPGs; Eon Mini™ IPG; Eterna SCS IPG• Associated SCS leads, extensions and accessories 2) Abbott Medical Deep Brain Stimulation Systems• Family of Infinity DBS IPGs; Liberta DBS IPG• Associated DBS leads, extensions and accessories 3) Abbott Medical dorsal root ganglion stimulation system: • Proclaim DRG IPG• Associated DRG leads, extensions and accessories
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