PMA P010032S260

Device: Proclaim family of SCS IPG
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S260
Product code: LGW
Decision date: 2026-09-23
Classification: Neurology
Generic name: Stimulator, spinal-cord, totally implanted 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 family of SCS IPG
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S260
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted 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.