PMA P140009S140

Device: Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) Charger
Applicant: ABBOTT MEDICAL
PMA number: P140009
Supplement: S140
Product code: MHY
Decision date: 2026-09-11
Classification: Neurology
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement: approval to utilize an alternate third-tier supplier for the FR-4 material, which is used in the manufacture of the printed circuit boards for the Chargers of the Eterna SCS IPG and Liberta RC DBS IPG

Current openFDA PMA Record#

Device: Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) Charger
Applicant: ABBOTT MEDICAL
PMA number: P140009
Supplement: S140
Product code: MHY
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Decision date: 2026-09-11
Decision code: OK30
Date received: 2026-08-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval to utilize an alternate third-tier supplier for the FR-4 material, which is used in the manufacture of the printed circuit boards for the Chargers of the Eterna SCS IPG and Liberta RC DBS IPG