PMA P140009S121

Device: Liberta RC™ DBS IPG
Applicant: ABBOTT MEDICAL
PMA number: P140009
Supplement: S121
Product code: MHY
Decision date: 2025-09-07
Classification: Neurology
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement: Approval for four alternate components which will be utilized on Printed Circuit Board Assembly (PCBA) for Abbott’s EternaTM SCS and Liberta RCTM Implantable Pulse Generator.

Current openFDA PMA Record#

Device: Liberta RC™ DBS IPG
Applicant: ABBOTT MEDICAL
PMA number: P140009
Supplement: S121
Product code: MHY
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Decision date: 2025-09-07
Decision code: APPR
Date received: 2025-06-09
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for four alternate components which will be utilized on Printed Circuit Board Assembly (PCBA) for Abbott’s EternaTM SCS and Liberta RCTM Implantable Pulse Generator.