- Device
- Axium Neurostimulator System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150004
- Supplement
- S069
- Product code
- PMP
- Generic name
- Dorsal root ganglion stimulator for pain relief
- Decision date
- 2024-10-08
- Decision code
- APPR
- Date received
- 2024-02-22
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- 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