PMA P010032

Device: Etema™ Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S194
Product code: LGW
Decision date: 2026-07-02
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
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: Etema™ Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)
Applicant: ABBOTT MEDICAL
PMA number: P010032
Supplement: S253
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
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