PMA P140009S133

Device: Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)
Applicant: ABBOTT MEDICAL
PMA number: P140009
Supplement: S133
Product code: MHY
Decision date: 2026-08-07
Classification: Neurology
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement: Approval for an alternate solder bumping site and a replacement per- and polyfluoroalkyl substances (PFAS)-free passivation layer material used in production of Bluetooth® (BLE) integrated circuit (IC) Chips at third-tier supplier, Nordic.

Current openFDA PMA Record#

Device: Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)
Applicant: ABBOTT MEDICAL
PMA number: P140009
Supplement: S133
Product code: MHY
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Decision date: 2026-08-07
Decision code: APPR
Date received: 2026-06-08
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for an alternate solder bumping site and a replacement per- and polyfluoroalkyl substances (PFAS)-free passivation layer material used in production of Bluetooth® (BLE) integrated circuit (IC) Chips at third-tier supplier, Nordic.