PMA P150004S082

Device: Dorsal Root Ganglion (DRG) External Pulse Generator (EPG)
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S082
Product code: PMP
Decision date: 2025-03-12
Classification: Neurology
Generic name: Dorsal root ganglion stimulator for pain relief
Approval order statement: Approval for a change to the conformal coating material used for the printed circuit board (PCB) of the External Pulse Generator (EPG) Base.

Current openFDA PMA Record#

Device: Dorsal Root Ganglion (DRG) External Pulse Generator (EPG)
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S082
Product code: PMP
Generic name: Dorsal root ganglion stimulator for pain relief
Decision date: 2025-03-12
Decision code: APPR
Date received: 2024-12-16
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a change to the conformal coating material used for the printed circuit board (PCB) of the External Pulse Generator (EPG) Base.