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: Dorsal Root Ganglion (DRG) SlimTip™ Trial Lead Kit and DRG SlimTip™ Implant Lead Kit
• Generic Name: Dorsal root ganglion stimulator for pain relief
• Applicant: ABBOTT MEDICAL; 6901 Preston Rd.; Plano, TX 75024
• PMA Number: P150004
• Supplement Number: S068
• Date Received: 10/13/2023
• Decision Date: 01/10/2024
• Product Code: PMP
• Advisory Committee: Neurology
• Supplement Type: Real-Time Process
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
for a minor packaging configuration change to the Dorsal Root Ganglion (DRG) SlimTip™ Trial Lead Kit and DRG SlimTip™ Implant Lead Kit.