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: Axium Neurostimulator System
• Generic Name: Dorsal root ganglion stimulator for pain relief
• Applicant: ABBOTT MEDICAL; 6901 Preston Rd.; Plano, TX 75024
• PMA Number: P150004
• Supplement Number: S001
• Date Received: 03/11/2016
• Decision Date: 05/26/2016
• Product Code: PMP
• Advisory Committee: Neurology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol - OSB
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval of the post-approval study protocol.