| 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 | Genesis Neurostimulation System |
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| Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
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| Applicant | ABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024 |
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| PMA Number | P010032 |
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| Supplement Number | S211 |
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| Date Received | 02/22/2024 |
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| Decision Date | 10/08/2024 |
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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 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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