PMA P150004

Device: Proclaim DRG IPG
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S057
Product code: PMP
Decision date: 2026-09-23
Generic name: Dorsal root ganglion stimulator for pain relief
Approval order statement: approval for a material change to the encapsulant used in the printed circuit board assembly (PCBA) during the manufacture of the Proclaim Spinal Cord Stimulator (SCS), Proclaim Dorsal Root Ganglion (DRG) stimulator and Infinity Deep Brain Stimulator (DBS) Implantable Pulse Generator (IPG) devices.

Current openFDA PMA Record#

Device: Proclaim DRG IPG
Applicant: ABBOTT MEDICAL
PMA number: P150004
Supplement: S100
Product code: PMP
Generic name: Dorsal root ganglion stimulator for pain relief
Decision date: 2026-09-23
Decision code: APPR
Date received: 2026-06-29
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for a material change to the encapsulant used in the printed circuit board assembly (PCBA) during the manufacture of the Proclaim Spinal Cord Stimulator (SCS), Proclaim Dorsal Root Ganglion (DRG) stimulator and Infinity Deep Brain Stimulator (DBS) Implantable Pulse Generator (IPG) devices.