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: Proclaim Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG)
• Generic Name: Dorsal root ganglion stimulator for pain relief
• Applicant: ABBOTT MEDICAL; 6901 Preston Rd.; Plano, TX 75024
• PMA Number: P150004
• Supplement Number: S060
• Date Received: 04/07/2023
• Decision Date: 05/04/2023
• Product Code: PMP
• Advisory Committee: Neurology
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Implement an alternative to batch testing for bacterial endotoxin testing performed at the Plano, TX facility for Proclaim DRG and Eterna IPGs.