Premarket Approval (PMA)

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.

• Device: Genesis And Eon Family Neurostimulation (IPG) Systems
• Generic Name: Stimulator, spinal-cord, totally implanted for pain relief
• Applicant: Abbott Medical; 6901 Preston Road; Plano, TX 75024
• PMA Number: P010032
• Supplement Number: S133
• Date Received: 08/10/2017
• Decision Date: 09/06/2017
• Product Code: LGW
• 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  
Updates to the sterilization equipment and bioburden test site.