PMA P140009

Device: Liberta RC™ Deep Brain Stimulation (DBS) IPG
Applicant: ABBOTT MEDICAL
PMA number: P140009
Supplement: S080
Product code: MHY
Decision date: 2026-07-02
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement: for new equipment qualification at a third-tier supplier of the Printed Circuit Board utilized in Abbott's Etema Spinal Cord Stimulation and Liberta Rechargeable Deep Brain Stimulation Implantable Pulse Generators

Current openFDA PMA Record#

Device: Liberta RC™ Deep Brain Stimulation (DBS) IPG
Applicant: ABBOTT MEDICAL
PMA number: P140009
Supplement: S132
Product code: MHY
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Decision date: 2026-07-02
Decision code: OK30
Date received: 2026-06-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: for new equipment qualification at a third-tier supplier of the Printed Circuit Board utilized in Abbott's Etema Spinal Cord Stimulation and Liberta Rechargeable Deep Brain Stimulation Implantable Pulse Generators