PMA P140009

Device: Infinity DBS IPG
Applicant: ABBOTT MEDICAL
PMA number: P140009
Supplement: S080
Product code: MHY
Decision date: 2026-09-23
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
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: Infinity DBS IPG
Applicant: ABBOTT MEDICAL
PMA number: P140009
Supplement: S139
Product code: MHY
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
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.